Associate Scientist jobs at PTC Therapeutics - 35 jobs

**R1 Associate Scientist, Chemistry:** The Analytical Commercialization Technology group currently has an exciting opportunity for an Associate Scientist at our Rahway, NJ site. The position is a laboratory-based scientific role in a fast-paced, multidisciplinary team environment. In this role, you will be supporting product formulation and process development and commercialization for our Company's new products utilizing various analytical techniques. Responsibilities include, but are not limited to: + Analytical testing for process and product characterization + Analytical method development and validation + Stability testing + Contribute to relevant analytical sections of regulatory submissions You will have the opportunity to collaborate with teams of scientists to effectively coordinate efforts and track progress for multiple projects. This position provides you with many opportunities to keep abreast of innovative and novel scientific developments in the pharmaceutical industry by presenting your own work at meetings, attending seminars, and interacting with industry leading scientists. **Education Minimum Requirement:** + BS/BA in Chemistry or other related physical sciences discipline **Required Experience and Skills:** + Demonstrated problem solving ability + Experience with common analytical techniques + Strong written and oral communication skills + Effective teamwork and collaboration skills, and time management skills **Preferred Experience and Skills:** + Experience with analytical techniques relevant to pharmaceutical development, such as HPLC, UV, IR, Karl Fischer, and dissolution with proven ability in troubleshooting these methodologies. **Required Skills:** Accountability, Accountability, Analytical Chemistry, Analytical Development, Analytical Testing, Bioanalytical Analysis, Biophysics, Chemical Biology, Chemical Physics, Chemical Synthesis, Collaborative Communications, Data Analysis, Data Management, Dosage Forms, Drug Development, Environmental Measurements, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Innovation, Interdisciplinary Collaboration, Machine Learning (ML), Molecular Structure, Multidisciplinary Collaboration, Oral Communications, Pharmaceutical Development {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $71,900.00 - $113,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R379846

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. **Responsibilities:** This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. **Primary Activities:** + Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices + Maintain and manage a project plan including resource forecasting + Coordinate the activities of a global programming team that includes outsource provider staff + Membership on departmental strategic initiative teams **Skills:** _Education and Minimum Requirement:_ + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment _Department Required Skills and Experience:_ + Effective interpersonal skills and ability to negotiate and collaborate effectively + Effective written, oral, and presentation skills + Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) + A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders _Position Specific Required Skills and Experience:_ + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise + Designs and develops complex programming algorithms + Ability to comprehend analysis plans which may describe methodology to be programmed; an understanding of statistical terminology and concepts + Familiarity with clinical data management concepts + Experience in CDISC and ADaM standards + Experience ensuring process compliance and deliverable quality + Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices + Ability to anticipate stakeholder requirements **Preferred Skills and Experience:** + Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) + US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables + Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor + Ability and interest to work across cultures and geographies + Ability to complete statistical programming deliverables through the use of global outsource partner programming staff + Experience developing and managing a project plan using Microsoft Project or similar package + Active in professional societies + Experience in process improvement eligiblefor ERP Bards2020 SPjobs VETJOB EBRG **Required Skills:** CDISC ADaM, Clinical Testing, Database Management Systems (DBMS), Data Management, Data Modeling, Numerical Analysis, Outcomes Research, Project Management, Project Planning, SAS Macros, Software Development, Stakeholder Relationship Management, Statistical Analysis Software (SAS), Statistical Programming, Waterfall Model **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R364171

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for late-stage drug/vaccine clinical development projects. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices Maintain and manage a project plan including resource forecasting Coordinate the activities of a global programming team that includes outsource provider staff Membership on departmental strategic initiative teams Skills: Education and Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment Department Required Skills and Experience: Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Position Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Ability to anticipate stakeholder requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor Ability and interest to work across cultures and geographies Ability to complete statistical programming deliverables through the use of global outsource partner programming staff Experience developing and managing a project plan using Microsoft Project or similar package Active in professional societies Experience in process improvement eligiblefor ERP BARDS2020 SPjobs VETJOBS EBRG Required Skills: Accountability, Clinical Development, Clinical Trials, Computer Science, Database Management Systems (DBMS), Data Management, Data Modeling, Innovation, Machine Learning (ML), Numerical Analysis, Outcomes Research, Project Management, Project Planning, SAS System, Software Development, Stakeholder Relationship Management, Statistical Programming, Statistical Software, Waterfall Model Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming analysis and reporting and regulatory submission deliverables for Real World Evidence projects across our Company Biostatistics and Research Decision Sciences (BARDS) group. The senior statistical programmer utilizes multiple programming languages including SAS and R to efficiently manipulate electronic healthcare databases to discover disease prevalence and risk factors, describe drug utilization patterns and disease progression, answer clinical development questions, and support regulatory submissions using Real World Data. In this role, the senior statistical programmer will gather and interpret user requirements from BARDS epidemiologists, retrieve the required data from electronic healthcare databases, and develop disease cohorts, analytical datasets, tables, figures, and submission deliverables and perform validation activities following departmental SOPs. The senior statistical programmer will be a key collaborator with BARDS epidemiologists and partner with study teams to effectively implement RWE standards to execute project plans efficiently. Position Qualifications: Education Minimum Requirement: MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 3 yrs experience in SAS and\or R BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related analytical field plus 5 yrs experience in SAS and\or R Department Required Skills and Experience: Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) A project leader; completes tasks independently at a project level, determines approach and ensures consistency, manages timelines Position Specific Required Skills and Experience: Significant expertise in SAS and\or R programming including data manipulation, statistical analysis, and graphics and tabulation techniques Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe observational research and statistical methodology to be programmed, an understanding of observational research or statistical terminology and concepts Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Ability to anticipate stakeholder requirements Preferred Experience and Skills: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) Experience handling non-standard data in a variety of formats with minimal requirements Programming expertise with electronic healthcare databases (electronic medical records and insurance claims); efficiently manipulates large databases including complex data preprocessing, filtering, and manipulation; experience with sampling strategies for large databases Expertise in SAS and\or R Real World Evidence programming including data processing, statistical procedures and graphing and tabulation techniques; systems and database expertise; SQL experience; coding systems such ICD-9, ICD-10, CPT, NDC, LOINC; data standards like Common Data Model (CDM); version control tools Familiarity with the fields of Outcomes Research and Epidemiology including methodologies Solid RWE and RWD domain knowledge Experience in process improvement; utilizes and contributes to the development of standard departmental SAS macros, R packages and tools Unix operating system experience; SQL experience; systems and database experience Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor Familiarity with statistics, clinical and data management concepts as applied to drug/vaccine development within the pharmaceutical industry Demonstrated success in the creation of regulatory compliant CDISC ADaM standards, including mapping US and/or worldwide drug or vaccine regulatory application submission experience including the development of electronic submission deliverables Experience eliciting user requirements and documenting programming specifications Team oriented with demonstrated history of teamwork and collaboration; enjoying diversity, respect and integrity; Ability and interest to work across cultures and geographies An interest to advance career by investing in development activities and taking on tasks with increasing levels of challenge and responsibility Active in professional societies eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG Required Skills: Accountability, Clinical Development, Computer Science, Database Management Systems (DBMS), Data Management, Data Modeling, Electronic Medical Record (EMR) Systems, Electronic Submissions, Epidemiology, Innovation, Machine Learning (ML), Numerical Analysis, Observational Studies, Pharmaceutical Development, REMOTE_SKILL-1-52891, Software Development, Stakeholder Relationship Management, Statistical Analysis, Statistical Programming, Waterfall Model Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/23/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Responsibilities: This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. Primary Activities: Effective analysis and report programming development and validation, utilizing global and therapeutic area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practice. Maintain and manage a project plan including resource forecasting. Coordinate the activities of a global programming team that includes outsourced provider staff. Membership on departmental strategic initiative teams Education and Minimum Requirement: BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment Department Required Skills and Experience: Effective interpersonal skills and ability to negotiate and collaborate effectively Effective written, oral, and presentation skills Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders Position Specific Required Skills and Experience: Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise Designs and develops complex programming algorithms Ability to comprehend analysis plans which may describe the methodology to be programmed; an understanding of statistical terminology and concepts Familiarity with clinical data management concepts Experience in CDISC and ADaM standards Experience ensuring process compliance and deliverable quality Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices Ability to anticipate stakeholder requirements Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) Oncology clinical trial programming experience is preferred. AI/Machine learning experience and knowledge is preferred. Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor Ability and interest to work across cultures and geographies Ability to complete statistical programming deliverables through the use of global outsource partner programming staff Experience developing and managing a project plan using Microsoft Project or similar package Active in professional societies Experience in process improvement eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG Required Skills: Accountability, Clinical Development, Clinical Trials, Computer Science, Data Management, Data Modeling, Innovation, Microsoft Project, Numerical Analysis, Project Leadership, Project Management, Project Planning, Resource Forecasting, R Programming, SAS Language, Software Development, Stakeholder Relationship Management Preferred Skills: Artificial Intelligence (AI), Machine Learning (ML), Oncology Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/23/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. **Responsibilities** **:** This position supports statistical programming activities for Early Oncology clinical development projects, Aggregated Safety Analysis and Secondary Publication. This may include leadership of one or more projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g., safety and efficacy analysis datasets, tables, listings, figures) for early oncology studies. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. **Primary Activities** **:** + Effective analysis and report programming development and validation, utilizing global and therapeutic area (TA) standards and following departmental standard operating procedures (SOPs) and good programming practice. + Maintain and manage a project plan including resource forecasting. + Coordinate the activities of a global programming team that includes outsourced provider staff. + Membership on departmental strategic initiative teams **Education and Minimum Requirement** **:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5-9 years SAS/R programming experience in a clinical trial environment + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3-7 years SAS/R programming experience in a clinical trial environment **Department Required Skills and Experience:** + Effective interpersonal skills and ability to negotiate and collaborate effectively + Effective written, oral, and presentation skills + Effective knowledge and experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) + A project leader; completes tasks independently at a project level; ability to collaborate with key stakeholders **Position Specific Required Skills and Experience:** + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise + Designs and develops complex programming algorithms + Ability to comprehend analysis plans which may describe the methodology to be programmed; an understanding of statistical terminology and concepts + Familiarity with clinical data management concepts + Experience in CDISC and ADaM standards + Experience ensuring process compliance and deliverable quality + Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices + Ability to anticipate stakeholder requirements **Preferred Skills and Experience:** + Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) + Oncology clinical trial programming experience is preferred. + AI/Machine learning experience and knowledge is preferred. + Experience assuring programming consistency across protocols and projects, directing the program development effort of other programmers; experience as a programming mentor + Ability and interest to work across cultures and geographies + Ability to complete statistical programming deliverables through the use of global outsource partner programming staff + Experience developing and managing a project plan using Microsoft Project or similar package + Active in professional societies + Experience in process improvement eligiblefor ERP SPjobs BARDS2020 VETJOBS EBRG **Required Skills:** Accountability, Clinical Development, Clinical Trials, Computer Science, Data Management, Data Modeling, Innovation, Microsoft Project, Numerical Analysis, Project Leadership, Project Management, Project Planning, Resource Forecasting, R Programming, SAS Language, Software Development, Stakeholder Relationship Management **Preferred Skills:** Artificial Intelligence (AI), Machine Learning (ML), Oncology Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R378645

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company's renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position provides high quality statistical programming deliverables for global stakeholders in Early Development Statistics and PK/PD Modeling and Simulation spanning all our company therapeutic areas except oncology. The senior statistical programmer will gather and interpret user requirements for programming requests, retrieve required data, transform data into analysis/modeling datasets, and develop tables, listings and figures according to statistical/modeling analysis plan. The senior programmer will be a key collaborator with statisticians, modelers, and colleagues in other related function areas. **Primary Activities** **:** + Prepare compliant programming code for regulatory submissions including analysis/modeling datasets, tables, listings, figures and associated documentation + Ensure programmatic traceability from data source to analysis/modeling result + Support the development of programming standards to enable efficient and high-quality production of programming deliverables **Education and Minimum Requirement** **:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 5 years SAS programming experience in a clinical trial environment + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 3 years SAS programming experience in a clinical trial environment **Department Required Skills and Experience:** + Excellent communication (oral, written) skills, interpersonal skills and ability to negotiate and collaborate effectively + Effective knowledge and experience in developing analysis and reporting deliverables for research and development projects (data, analyses, tables, graphics, listings) + A project leader; completes tasks independently at project level **Position Specific Required Skills and Experience:** + Programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters) + Experience with at least one other software than SAS (e.g., R, Python, NonMem) + Experience in CDISC SDTM and ADaM standards + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH + Designs and develops complex programming algorithms + Ability to comprehend analysis plans which may describe methodology to be programmed; understanding of statistical terminology and concepts; Implements statistical methods not currently available through commercial software packages. **Preferred Skills and Experience:** + Familiarity with clinical pharmacology concepts and pharmacokinetics concepts + Good working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC) + Utilizes and contributes to the development of standard departmental SAS macros + Ability and interest to work across cultures and geographies + Ability to complete statistical programming deliverables through the use of global outsource partner programming staff + Active in professional societies \#BARDS2020 SPjobs VETJOBS EBRG **Required Skills:** Clinical Testing, Computer Science, Data Management, Data Modeling, Mechatronics, Numerical Analysis, SAS Graphs, Software Development, Stakeholder Relationship Management, Statistical Analysis Software (SAS), Statistical Methods, Statistical Programming, Systems Development Lifecycle (SDLC), Waterfall Model **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $114,700.00 - $180,500.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R367015

The 2-year Physician Scientist Program provides pharmaceutical medicine training and opportunities to physicians completing residency or fellowship with the goal of recruiting new talent and contributing to the organization's inclusion objectives. The program provides in-depth exposure to clinical drug development with emphasis on key elements of clinical trial planning, execution, data analysis and reporting of clinical trial results. Physician Scientists will develop skills working with clinical and cross-functional teams as clinical programs progress toward regulatory approvals. Successful candidates will spend their first year in one of the following areas: (a) Global Clinical Development: Understand the role and methods of pharmaceutical research, participate in the writing of research protocols, conduct of clinical trials, safety monitoring, analysis of data and communication of study findings; (b) Global Regulatory Affairs and Clinical Safety: Focus on late-stage and lifecycle drug activities, understand key regulatory policies and the procedures for interacting with health agencies (e.g. FDA); understand key elements in pharmacovigilance, drug safety monitoring, signal detection and processing of adverse reports; (c) Global Medical/Scientific Affairs: Exposure to the management of a product asset prior to, during and after the launch phase (US and Global) including caveats on drug promotion. After a successful first year, the Physician Scientist will be equipped to assume a leading role in the team with additional responsibilities and interactions. The Physician Scientist also has the opportunity to do a second 1-year rotation in another area instead. Required Education and Experience: Candidates must currently hold an MD degree and have completed residency or fellowship training in an accredited US medical program, preferably within the last 5 years. Required Skills: Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Communication, Drug Development, Drug Research, Ethical Standards, Good Clinical Practice (GCP), Medical Research, Medical Writing, Pharmaceutical Research, Pharmacy Regulation, Protocol Development, Regulatory Policies, Research Proposals, Scientific Consulting, Scientific Research Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $190,800.00 - $300,300.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

This position resides within our company's Value and Implementation (V&I), Outcomes Research Oncology organization, which is responsible for real-world evidence generation and outcomes research to enable sustained patient access to our company's innovations and improve patient health outcomes. Under the guidance of senior leaders, this individual will support the V&I, Outcomes Research teams in Hematology. Primary Responsibilities: Support the value evidence team in hematology and contribute to value evidence strategies for in-line and pipeline products. Serve as outcomes research representative on cross-functional regional and global teams. Critically assess drivers/barriers to reimbursement and market access, and identify relevant value evidence data gaps from clinical, medical, regulatory, payer/access, and marketing stakeholders to define integrated evidence generation plans. In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications. Present outcomes research data at national and international congresses and publish articles in scientific journals. Work closely with cross functional teams, including medical affairs partners, to effectively communicate real-world evidence internally and to external stakeholders. Develop American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers. Support local/regional country affiliates to understand local evidence generation needs, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements. Hold responsibility for study-related contracting, budgets, and vendor/partner management. Maintain awareness of new scientific and methodological developments within therapeutic area and in outcomes research field. Build relationships with scientific experts worldwide. Qualifications Preferred : Doctoral degree (PhD, DrPH, ScD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration). Required Experience: Master's degree (MSc, MPH) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration). Required Experience: A minimum of 1 year of relevant work experience with a doctoral degree A minimum of 3 years of relevant work experience with a master's degree Required Skills: Computer Science, Data Management, Epidemiology, Health Economics, Health Outcomes Research, Health Sciences, Health Sciences Research, Hematology, Machine Learning (ML), Medical Teamwork, Outcomes Research, Pathophysiology, Pharmacodynamics, Pharmacoeconomics, Pharmacokinetics, Public Health, Stakeholder Relationship Management, Strategic Planning Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $153,800.00 - $242,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/28/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

This position resides within our company's Value and Implementation (V&I), Outcomes Research Oncology organization, which is responsible for real-world evidence generation and outcomes research to enable sustained patient access to our company's innovations and improve patient health outcomes. Under the guidance of senior leaders, this individual will support the V&I, Outcomes Research teams in Hematology. **Primary Responsibilities:** + Support the value evidence team in hematology and contribute to value evidence strategies for in-line and pipeline products. Serve as outcomes research representative on cross-functional regional and global teams. + Critically assess drivers/barriers to reimbursement and market access, and identify relevant value evidence data gaps from clinical, medical, regulatory, payer/access, and marketing stakeholders to define integrated evidence generation plans. + In collaboration with internal teams and external partners, design studies, author study protocols, develop measurement questionnaires, case report forms, data analysis plans, final study reports, scientific presentations, and publications. + Present outcomes research data at national and international congresses and publish articles in scientific journals. + Work closely with cross functional teams, including medical affairs partners, to effectively communicate real-world evidence internally and to external stakeholders. + Develop American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers. + Support local/regional country affiliates to understand local evidence generation needs, customize outcomes research documents, such as protocols and reimbursement dossiers, according to local requirements. + Hold responsibility for study-related contracting, budgets, and vendor/partner management. + Maintain awareness of new scientific and methodological developments within therapeutic area and in outcomes research field. + Build relationships with scientific experts worldwide. **Qualifications** **Preferred :** + Doctoral degree (PhD, DrPH, ScD) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration). **Required Experience:** + Master's degree (MSc, MPH) in relevant discipline (health services research, outcomes research, epidemiology, public health, health economics, Pharmacoeconomics, pharmacy administration). **Required Experience:** + A minimum of 1 year of relevant work experience with a doctoral degree + A minimum of 3 years of relevant work experience with a master's degree **Required Skills:** Computer Science, Data Management, Epidemiology, Health Economics, Health Outcomes Research, Health Sciences, Health Sciences Research, Hematology, Machine Learning (ML), Medical Teamwork, Outcomes Research, Pathophysiology, Pharmacodynamics, Pharmacoeconomics, Pharmacokinetics, Public Health, Stakeholder Relationship Management, Strategic Planning **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $153,800.00 - $242,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/28/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R379078

Associate Principal Scientist, Analytical Commercialization Technology The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not limited to, analytical method development and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. The ideal candidate will have knowledge and proficiency in the following areas: separation techniques and aerosol science. Prior experience with inhalation product development and characterization is highly desired. Applicants must have effective organizational skills, multi-tasking, oral and written communications skills. Education Minimum Requirements: PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience. Required Experience and Skills: Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution Experience with inhalation product characterization including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD) Strong chemistry knowledge Demonstrated problem solving ability Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills Ability to work in a team environment with cross-functional interactions Preferred Experience and Skills: Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies Experience with method development and validation Familiarity with authoring relevant CMC sections of regulatory submissions Required Skills: Analytical Chemistry, Analytical Development, Chemical Biology, Chemical Processing, Chemical Synthesis, Chromatography, Computational Chemistry, Data Analysis, Enzymology, Experimental Development, Gas Chromatography Analysis, Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), Infrared Spectroscopy, Karl Fischer Titrations, Machine Learning (ML), Molecular Structure, Pharmaceutical Development, Spectrophotometry, Synthetic Chemistry Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/23/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high-quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. Key areas of focus include (1) the assurance of deliverable quality and process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic knowledge-base data model, (3) maintaining and managing a project plan including resource forecasting, (4) coordinating the activities of a global programming team that includes outsource provider staff, (5) membership on departmental strategic initiative project teams such as new statistical computing platform evaluation and development. **Education and Minimum Requirement:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineeringor related field plus 9 years SAS programming experience in a clinical trial environment. + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering orrelated field plus 7 or more years SAS programming experience in a clinical trial environment. **Department Required Skills and Experience:** + Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team. + Broad knowledge and significant experience in developing analysis and reporting statistical programming deliverables (datasets, statistical analyses, report tables, and graphics) using global and TA standards and according to quality, compliance and timeliness requirements. + Expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. Familiarity with statistical analysis methods and clinical data management concepts. + US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables. + Strong project management skills; A program leader; Determines appropriate programming methodology, assures programming consistency across protocols and projects, completes programming tasks, and directs the program development effort of other programmers; an experienced programming mentor; ability to engage key stakeholders. + Ability to comprehend statistical analysis plans which may describe statistical methodology to be programmed; Understanding of statistical terminology and concepts Designs and develops complex programming algorithms. + Excellent communication and negotiation skills with a demonstrated history of teamwork and collaboration; deals well with change and seamlessly assimilates to new projects and stakeholders. + Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices. + Experience in CDISC and ADaM standards. + Demonstrated success in the assurance of deliverable quality and process compliance. + Ability to anticipate stakeholder and regulatory requirements. **Preferred Experience and Skills:** + Strong working knowledge of reporting processes (SOPs) and software development life-cycle (SDLC). + Ability and interest to work across cultures and geographies. + Experience providing technical and/or programming guidance and mentoring to colleagues. + Ability to complete statistical programming deliverables through the use of global outsource partner programming staff. + Experience developing and managing a project plan using Microsoft Project or similar package. + Active in professional societies. + Experience in process improvement. eligiblefor ERP BARDS2020 SPJOBS VETJOBS \#EBRG **Required Skills:** Accountability, Clinical Development, Computer Science, Data Management, Data Modeling, Innovation, Machine Learning (ML), Microsoft Project, Numerical Analysis, Outcomes Research, Pharmaceuticals Marketing, Process Improvements, REMOTE_SKILL-1-52891, Resource Forecasting, Software Development, Stakeholder Engagement, Stakeholder Relationship Management, Statistical Analysis, Statistical Programming, Waterfall Model **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/26/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R380964

**Associate Principal Scientist, Analytical Commercialization Technology** The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not limited to, analytical method development and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. The ideal candidate will have knowledge and proficiency in the following areas: separation techniques and aerosol science. Prior experience with inhalation product development and characterization is highly desired. Applicants must have effective organizational skills, multi-tasking, oral and written communications skills. **Education Minimum Requirements:** PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience. **Required Experience and Skills:** + Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution + Experience with inhalation product characterization including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD) + Strong chemistry knowledge + Demonstrated problem solving ability + Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills + Ability to work in a team environment with cross-functional interactions **Preferred Experience and Skills:** + Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies + Experience with method development and validation + Familiarity with authoring relevant CMC sections of regulatory submissions **Required Skills:** Analytical Chemistry, Analytical Development, Chemical Biology, Chemical Processing, Chemical Synthesis, Chromatography, Computational Chemistry, Data Analysis, Enzymology, Experimental Development, Gas Chromatography Analysis, Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), Infrared Spectroscopy, Karl Fischer Titrations, Machine Learning (ML), Molecular Structure, Pharmaceutical Development, Spectrophotometry, Synthetic Chemistry **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/23/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R380190

We are currently seeking an Associate Principal Scientist (Engineer) for our Pharmaceutical Commercialization Technology (PCT) team. PCT is responsible for pharmaceutical process development of primarily oral solid dosage forms from Phase IIb through regulatory filings, process performance qualification, and into commercial supply. Our work is supported by development facilities in West Point, PA, and Rahway, NJ, a primary commercialization site in Ireland, and a global network of internal and external supply sites. The Associate Principal Scientist will serve as a key technical and business leader, overseeing process development activities for a segment of the late-stage pharmaceutical project portfolio. This role leads teams responsible for creating and executing process development plans, aligning with clinical supply plans, developing and documenting the knowledge base needed for regulatory filings, and managing the project through early launch and supply steps. The Associate Principal Scientist also ensures that interfaces with relevant partner groups - upstream, downstream, and parallel - are managed collaboratively, efficiently, and effectively. The successful candidate may lead high-impact, complex, cross-functional teams and initiatives,. The Associate Principal Scientist will champion cultural change to support and realize PCT's and our company's vision, driving technical excellence and understanding. The Associate Principal Scientist should have fluency in risk-based approaches to development, design of experiments, and process modeling. Proficiency in scientific writing is essential for preparing technical reports and authoring CTD sections to support product registration efforts. Primary activities include, but are not limited to: **Advance the pipeline:** + Decides on development plans and outcomes for Final Market Formulations and commercial processes + As project team leader, develops high-performing teams, or as a key member of multiple smaller teams influences direction for optimal solutions based on use of systematic planning, risk and options analysis tools. Escalates issues appropriately for visibility and resolution **Technical expertise and technology development:** + Acts as Subject Matter Expert (SME) in technical areas in order to efficiently solve problems using appropriate tools and prior knowledge. + Has fluency of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues. + Supports technical capability build and knowledge sharing within organization + Technical depth and breadth in all aspects of solid dosage form and process development, including standard and enabled formulations and processes, characterization techniques, experimental data analysis and modeling, including statistical and first principal approaches. + Leads application of process development in accordance with ICH principles in regulatory filings, with an emphasis on process robustness and flexibility with business benefits using enhanced and traditional control strategies. **Build capability and strategic thinking:** + Makes informed cost/benefit decisions based on analysis of inputs, risk and likely return, and takes ownership of the outcomes. + Influences departmental strategy and tactics, particularly with regard to technical issues + Leverages communication mechanisms and business processes to facilitate decision making and leverages the collective experience of the organization + Influences interactions with key partner groups, and helps to set strategy and tactics across functions **Required Experience and Skills:** + Minimum education and experience:B.S., M.S., pr PhD in Engineering, Chemistry, or related engineering/scientific discipline required. + Relevant experience (B.S. +7 years, M.S. + 5 years, or PhD + 4 years) in oral solid dosage drug product development or closely related area. **Desired Experience and Skills:** Experience in one or more of the following areas is preferable but not required: + Spray Drying for Amorphous Solid Dispersions + Bilayer Compression + Process or formulation development for Peptide drug products and/or formulations using permeation enhancement + Process modelling, Discrete Element Modelling (DEM), Computational Fluid Dynamics (CFD) + Data analysis and digital expertise, including digital fluency in one or more of these areas: python, R, power BI, power apps, Generative AI as a productivity tool, data literacy and statistical reasoning + Technology Transfer between Sites \#EBRG **Required Skills:** Data Analytics, Design of Experiments (DOE), Detail-Oriented, Process Design, Process Optimization, Process Scale Up, Solid Dosage Forms, Statistical Literacy **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 01/19/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R380477

The Chemical Commercialization Technology (CCT) department, which is part of our company Manufacturing Division is seeking a self-motivated individual who is looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work. The Associate Principal Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline. The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities. Mentoring is required to develop junior staff to initiate, plan and execute characterization and complete technical support objectives. The scientist will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). **Position Qualifications** **:** **Education Minimum Requirement:** + The position requires a BS and/or MS in Chemical Engineering or a related field from an accredited college/university plus at least 8 years of relevant work experience in process development or PhD with at least 4 years of relevant work experience post PhD defense. **Required Experience and Skills:** Relevant work experience in chemical process development, including the following: + Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity + Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory + Ability to mentor technical staff in the laboratory and through data analysis + Highly effective communication and collaboration skills + Good organizational, interpersonal, writing, and time management skills + Ability to operate within a cross-functional process development team **Preferred Experience and Skills:** + Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization + Experience leading regulatory file authoring, validation planning and execution + Experience guiding internal/external technical discussions + Familiarity with statistical design and analysis tools + Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting + Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles. **Required Skills:** Bioprocessing, Chemical Engineering, Chemical Technology, Data Analysis, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Protein Purifications, Regulatory Submissions, Technical Writing **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/20/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R378932

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (e.g. safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support. The incumbent is responsible for the design and maintenance of statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation. The position is a key collaborator with statistics and other project stakeholders in ensuring that project plans are executed efficiently with timely and high quality deliverables. For assigned projects the position serves as the statistical programming point of contact and knowledge holder through the entire product lifecycle. **Primary Activities** **:** + Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and good programming practices. + Maintain and manage a project plan including resource forecasting. + Coordinate the activities of a global programming team that includes outsource provider staff. + Membership on departmental strategic initiative teams **Education and Minimum Requirement** **:** + BA/BS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 9 years SAS programming experience in a clinical trial environment. + MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering or related field plus 7 or more years SAS programming experience in a clinical trial environment. **Department Required Skills and Experience:** + Excellent interpersonal skills and ability to negotiate and collaborate effectively. + Excellent written, oral, and presentation skills + Broad knowledge and significant experience in developing analysis and reporting deliverables for R&D projects (data, analyses, tables, graphics, listings) + Strong project management skills; leadership at a program level; determines approach and ensures consistency and directs development of others when opportunities arise; ability to engage key stakeholders. **Position Specific Required Skills and Experience:** + Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise. + Experience leading large and/or complex statistical programming projects that include coordinating the activities of a programming team. + US and/or worldwide drug or vaccine regulatory application submission experience at the leadership level including the development of electronic submission deliverables. + Designs and develops complex programming algorithms. + Ability to comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts. + Familiarity with clinical data management concepts + Experience in CDISC and ADaM standards + Demonstrated success in the assurance of deliverable quality and process compliance. + Strategic thinking - ability to turn strategy into tactical activities; design of statistical databases with the end in mind that optimize analysis and reporting and leverage departmental standards and industry best-practices. + Ability to anticipate stakeholder requirements. ****** **Preferred Skills and Experience:** + Strong working knowledge of reporting processes (SOPs) and software development life cycle (SDLC) + Experience providing technical and/or programming guidance and mentoring to colleagues. + Ability and interest to work across cultures and geographies. + Ability to complete statistical programming deliverables through the use of global outsource partner programming staff. + Experience developing and managing a project plan using Microsoft Project or similar package. + Active in professional societies + Experience in process improvement. \#eligiblefor ERP BARDS2020 SPJOBS VETJOBS \#EBRG **NOTICE** **FOR** **INTERNAL** **APPLICANTS** In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. _As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal_ _Opportunity Employment laws, visit:_ _EEOC Know Your Rights_ _EEOC GINA Supplement _ _We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively._ _Learn more about your rights, including under California, Colorado and other US State Acts (************************************************************************************************************************************************************************************************** **Required Skills:** **Preferred Skills:** Algorithms, Algorithms, Applied Mathematics, Biostatistics, Business Process Improvements, Business Strategies, Clinical Development, Clinical Research, Clinical Testing, Clinical Trial Designs, Clinical Trials, Cost Management, Creativity, Data Management, Geography, Initiative Activity, Leadership, Lean Process Improvements, Life Science, Long Term Planning, Maintenance Strategy, Marketing, Microsoft Project, New Program Development, Oncology {+ 21 more} Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $135,500.00 - $213,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** No Travel Required **Flexible Work Arrangements:** Hybrid **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 01/26/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R306311

We are seeking an experienced and innovative Associate Principal Scientist with a strong background in supporting _in vitro_ pharmacology for early drug discovery to join the External Quantitative Biosciences group (ExQB). Under the broad direction of a Principal Scientist in ExQB, the candidate will support the execution of externalized _In vitro_ biology projects across all discovery sites in our Research and Development division's disease areas, as well as participate in relationship management of Contract Research Organizations (CRO). The ideal candidate will be an experienced in vitro biology bench scientist and team player with experience supporting collaborations across a broad range of discovery biology disciplines. In collaboration with Quantitative Biosciences (QB), this individual will effectively assess and grow our external early discovery _in vitro_ biology capabilities to drive pipeline support in line with our company's broader externalization strategies. Strong communication, leadership, and problem-solving skills, as well as ability to network, apply soft skills, operate in the 'grey space', and apply excellent interpersonal skills are crucial to success in this role. **Key responsibilities include but are not limited to the following:** + Relying on in vitro biology lab bench experience, partner with pharmacologists from QB and scientists from other discovery functions to define and challenge resource demands and support the continued build of strategies, workflows, and capability builds at strategic CRO partners to support screening and external reagent generation in a rapidly changing environment. + Provide tactical and scientific support to transfer in vitro pharmacology/biology screening funnels, assays, technology, and processes in alignment with the unified screening strategy shared between ExQB, External Discovery Chemistry and DMPK outsourcing teams to maintain and improve Design, Make, Test, Analyze (DMTA) cycle time. + Plan and participate in partner site visits to evaluate in vitro biology workflows, practices, capabilities, safety procedures and compliance standards, as well as build and optimize workflows to complement internal company processes, including working with our company's IT to enable data transfer. + Oversee partner scientific workflows, and together with Discovery Operations team and procurement, manage the business relationship between our company and CROs through various governance meetings, processes, and performance feedback. + Work closely with Procurement and Business Development & Licensing teams to support business sourcing management and licensing needs by scientifically representing in vitro biology sourcing needs. + Routinely gather, categorize, and translate external resource demand across in vitro biology disciplines and share with Finance and Discovery Operations to manage and update spend forecasts **Required Experience and Skills:** + While this is not a lab-based position, this role requires substantial bench-level experience and expertise in _in vitro_ biology/pharmacology. As such, a minimum of a Bachelor's Degree (BA/BS) in Biology, _In Vitro_ Pharmacology, Pharmaceutical Science, Molecular Biology, Biochemistry, Biophysics, or a related STEM discipline with 8+ years of relevant industry lab experience, a Master's Degree (MA/MBA/MS) with 6+ years of relevant industry lab experience, or a PhD with 4+ years of relevant industry lab experience is required. + Lab-based expertise in applying plate-based _In Vitro_ pharmacology principles and best practices across multiple disease areas with experience in designing, interpreting, and troubleshooting studies, as well as significant experience in performing automated plate-based assays for DMTA/SAR support in a time-critical fashion is needed. + Working understanding of global pharmaceutical and CRO industries with a solid understanding of drug discovery, as well understanding pharmacology's role within drug discovery. **Preferred Experience and Skills:** + Expertise in biochemistry/protein biochemistry, biophysics, and/or molecular biology is strongly preferred + Strong understanding of in vitro pharmacology business standards including data QC, protocol design, laboratory processes and best-practices, as well as safety standards. + Expertise in cell pharmacology, lab automation, and/or discovery biomarker research including -omics + A minimum of 3 years in managing CRO relationships or equivalent relationship management role. + Established network within our company, as well as Strategic CROs, and biotech / large pharma. + Successful track record of working with multiple functional groups or teams across cultural and geographic boundaries. The location can be at any of our company's East Coast Research Laboratory locations (Research and Development Division) including Boston MA, Cambridge MA, Rahway NJ, or West Point PA sites. \#EligibleforERP **Required Skills:** Accountability, Accountability, Adaptability, Assay, Assay Development, Biochemical Assays, Biochemistry, Biology, Cell Biology, Contract Research Organizations (CROs), Detail-Oriented, Drug Discovery Process, Ethical Compliance, High-Throughput Screening, Innovation, In Vitro Pharmacology, In Vitro Research, In Vitro Studies, Leadership, Mammalian Cell Culture, Managing Ambiguity, Molecular Biology, Professional Networking, Protein Expression, Stakeholder Management {+ 2 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $144,800.00 - $227,900.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** Domestic **VISA Sponsorship:** Yes **Travel Requirements:** 25% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** Biological and chemical **Job Posting End Date:** 02/3/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381003

Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection. This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches. Principal Responsibilities Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements. Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT). Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms. Oversee and serve as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis. Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part. Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools. Maintain a high level of engagement in the program-specific design controls process and design history file development. Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others. Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities. Qualifications REQUIREMENTS: B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 10 years of combined experience in medical device and combination product development. Advanced degree is preferred. Leadership experience with working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product. Leadership experience of managing device or combination product development programs and leading cross-disciplinary project teams. Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy. Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc. Proven track record of applying analytical skills in product design, development, and validation Self-motivated with ability to work independently Proven ability to lead team members of diverse skill sets and backgrounds Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership Excellent communication, presentation, negotiation, project management, and organizational skills Experience with leading complex development projects at an enterprise level Willing to travel Able to multi-task continuously Required Skills: Combination Products, Combination Products, Communication, Computer Science, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development, Diversity Awareness, Human Factor Engineering, Injection Moldings, Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems, Medical Device Regulations, Medical Devices, Medical Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management, Quality Management Systems (QMS) {+ 4 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

_Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine - device enabled combination products to achieve safe and effective delivery to their intended site of action. The DPPD Team manages the development of the device constituent of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection._ This position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements. This position will lead cross-functional development teams within and external to Device Development & Technology. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development; manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and commercial combination product development and launches. **Principal Responsibilities** Lead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: + Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions. + Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements. + Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT). + Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms. + Oversee and serve as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis. + Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers + Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership. + Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part. + Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools. + Maintain a high level of engagement in the program-specific design controls process and design history file development. + Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others. + Enhance our Company's professional image and competitive advantage through publications, presentations, patents, and professional activities. **Qualifications** **REQUIREMENTS:** + B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 10 years of combined experience in medical device and combination product development. Advanced degree is preferred. + Leadership experience with working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes. Including development drug-device combination product or a medical device component of a combination product. + Leadership experience of managing device or combination product development programs and leading cross-disciplinary project teams. + Has broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy. + Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, 11608 and 11040, EN 62366, Council Directive 93/42/EEC, etc. + Proven track record of applying analytical skills in product design, development, and validation + Self-motivated with ability to work independently + Proven ability to lead team members of diverse skill sets and backgrounds + Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership + Excellent communication, presentation, negotiation, project management, and organizational skills + Experience with leading complex development projects at an enterprise level + Willing to travel + Able to multi-task continuously **Required Skills:** Combination Products, Combination Products, Communication, Computer Science, Cultural Diversity, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development, Diversity Awareness, Human Factor Engineering, Injection Moldings, Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems, Medical Device Regulations, Medical Devices, Medical Devices Design, Negotiation, Process Manufacturing, Product Design, Production Process Development, Project Management, Quality Management Systems (QMS) {+ 4 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $139,600.00 - $219,700.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** **VISA Sponsorship:** **Travel Requirements:** **Flexible Work Arrangements:** Hybrid **Shift:** **Valid Driving License:** **Hazardous Material(s):** **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R373798