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Principal Biostatistician jobs at QuintilesIMS - 764 jobs
Assoc Director, Data Scientist
Gilead Sciences, Inc.
Foster City, CA jobs
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Gilead's AI Research Center(ARC) is looking for a Principal Data Scientist to spearhead the adoption of AI/ML and transform our clinical development processes. This is a pivotal role where you will provide key thought leadership and drive our strategic vision for advanced analytics, with the goal of optimizing clinical trials, enhancing data-driven decision-making, and providing support for Real-World Evidence (RWE), Clinical Pharmacology, and Biomarkers initiatives. You will be a thought leader in applying AI/ML to real-world clinical challenges, taking deep involvement in all stages of technical development-from coding and configuring compute environments to model evaluation, review, and architecture design. You'll work closely with a variety of cross-functional teams, including architects, data engineers, and product managers, to scope, develop, and operationalize our AI-driven applications, with a specific focus on leveraging AI/ML to advance insights within RWE, Clinical Pharmacology, and Biomarkers. Responsibilities: Innovate and Strategize: Spearhead the strategic vision for leveraging AI/ML within clinical development. You'll partner with cross-functional leaders to identify high-impact opportunities and design innovative solutions that transform how we conduct trials and make data-driven decisions. Lead with Expertise: Guide the full lifecycle of machine learning models from initial concept to real-world application. This includes architecting scalable solutions, hands-on algorithm development, and ensuring models are rigorously evaluated and operationalized for use in RWE, Clinical Pharmacology, and Biomarkers. Mentor and Empower: Act as a force multiplier for our data science team. You'll coach and mentor senior and junior data scientists, fostering a culture of technical excellence and continuous learning. Translate and Execute: Serve as a bridge between technical teams and business stakeholders. You'll translate complex business challenges into precise data science problems and, in a product manager-like role, drive the development of these solutions from proof-of-concept to production. Drive Breakthroughs: Research and develop cutting-edge algorithms to solve critical challenges. This could involve using NLP for patient insights, computer vision for biomarker analysis, or predictive models to optimize trial logistics. You'll be at the forefront of applying these techniques in a biotech context. Build the Foundation: Design and implement the technical and process building blocks needed to scale our AI/ML capabilities. This includes working with IT partners to curate and operationalize the datasets essential for fueling our analytical pipelines. Influence and Advise: Interface directly with internal stakeholders, acting as a trusted advisor to help them understand the potential of advanced analytics and apply data-driven approaches to optimize clinical trial operations. Stay Ahead: Continuously monitor the landscape of machine learning and biopharmaceutical innovation. You'll ensure our team is leveraging the latest state-of-the-art techniques to maintain a competitive edge. Technical Skills: Advanced Model Development & Operationalization: Deep expertise in developing, deploying, and managing complex machine learning and deep learning algorithms at scale. This includes a profound understanding of model evaluation, scoring methodologies, and mitigation of model bias to ensure robust, ethical, and reliable outcomes. Data & Computational Proficiency: Fluent in Python or R and SQL, with hands-on experience in building and optimizing data pipelines for analytical and model development purposes. Cloud-Native AI/ML: Demonstrated experience with Cloud DevOps on AWS as it pertains to the entire data science lifecycle, from data ingestion to model serving and monitoring. Translational Research: Proven ability to translate foundational AI/ML research into functional, production-ready packages and applications that directly support strategic initiatives in areas like RWE, Clinical Pharmacology, and Biomarkers. Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications: Ability to translate stakeholder needs into clear technical requirements, including those related to RWE, Clinical Pharmacology, and Biomarkers. Skill in scoping project requirements and developing timelines. Knowledge of product management principles. Experience with code management using Git. Strong technical documentation skills. Join us at the AI Research Center to shape the future of clinical development with groundbreaking AI/ML solutions, and contribute to advancements in RWE, Clinical Pharmacology, and Biomarkers! The salary range for this position is: Bay Area: $210,375.00 - $272,250.00.Other US Locations: $191,250.00 - $247,500.00. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead's AI Research Center(ARC) is looking for a Principal Data Scientist to spearhead the adoption of AI/ML and transform our clinical development processes. This is a pivotal role where you will provide key thought leadership and drive our strategic vision for advanced analytics, with the goal of optimizing clinical trials, enhancing data-driven decision-making, and providing support for Real-World Evidence (RWE), Clinical Pharmacology, and Biomarkers initiatives. You will be a thought leader in applying AI/ML to real-world clinical challenges, taking deep involvement in all stages of technical development-from coding and configuring compute environments to model evaluation, review, and architecture design. You'll work closely with a variety of cross-functional teams, including architects, data engineers, and product managers, to scope, develop, and operationalize our AI-driven applications, with a specific focus on leveraging AI/ML to advance insights within RWE, Clinical Pharmacology, and Biomarkers. Responsibilities: Innovate and Strategize: Spearhead the strategic vision for leveraging AI/ML within clinical development. You'll partner with cross-functional leaders to identify high-impact opportunities and design innovative solutions that transform how we conduct trials and make data-driven decisions. Lead with Expertise: Guide the full lifecycle of machine learning models from initial concept to real-world application. This includes architecting scalable solutions, hands-on algorithm development, and ensuring models are rigorously evaluated and operationalized for use in RWE, Clinical Pharmacology, and Biomarkers. Mentor and Empower: Act as a force multiplier for our data science team. You'll coach and mentor senior and junior data scientists, fostering a culture of technical excellence and continuous learning. Translate and Execute: Serve as a bridge between technical teams and business stakeholders. You'll translate complex business challenges into precise data science problems and, in a product manager-like role, drive the development of these solutions from proof-of-concept to production. Drive Breakthroughs: Research and develop cutting-edge algorithms to solve critical challenges. This could involve using NLP for patient insights, computer vision for biomarker analysis, or predictive models to optimize trial logistics. You'll be at the forefront of applying these techniques in a biotech context. Build the Foundation: Design and implement the technical and process building blocks needed to scale our AI/ML capabilities. This includes working with IT partners to curate and operationalize the datasets essential for fueling our analytical pipelines. Influence and Advise: Interface directly with internal stakeholders, acting as a trusted advisor to help them understand the potential of advanced analytics and apply data-driven approaches to optimize clinical trial operations. Stay Ahead: Continuously monitor the landscape of machine learning and biopharmaceutical innovation. You'll ensure our team is leveraging the latest state-of-the-art techniques to maintain a competitive edge. Technical Skills: Advanced Model Development & Operationalization: Deep expertise in developing, deploying, and managing complex machine learning and deep learning algorithms at scale. This includes a profound understanding of model evaluation, scoring methodologies, and mitigation of model bias to ensure robust, ethical, and reliable outcomes. Data & Computational Proficiency: Fluent in Python or R and SQL, with hands-on experience in building and optimizing data pipelines for analytical and model development purposes. Cloud-Native AI/ML: Demonstrated experience with Cloud DevOps on AWS as it pertains to the entire data science lifecycle, from data ingestion to model serving and monitoring. Translational Research: Proven ability to translate foundational AI/ML research into functional, production-ready packages and applications that directly support strategic initiatives in areas like RWE, Clinical Pharmacology, and Biomarkers. Basic Qualifications: Doctorate and 5+ years of relevant experience OR Master's and 8+ years of relevant experience OR Bachelor's and 10+ years of relevant experience Preferred Qualifications: Ability to translate stakeholder needs into clear technical requirements, including those related to RWE, Clinical Pharmacology, and Biomarkers. Skill in scoping project requirements and developing timelines. Knowledge of product management principles. Experience with code management using Git. Strong technical documentation skills. Join us at the AI Research Center to shape the future of clinical development with groundbreaking AI/ML solutions, and contribute to advancements in RWE, Clinical Pharmacology, and Biomarkers! The salary range for this position is: Bay Area: $210,375.00 - $272,250.00.Other US Locations: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday. Share: Job Requisition ID R0046852 Full Time/Part Time Full-Time Job Level Associate Director Click below to return to the Gilead Careers site Click below to see a list of upcoming events Click below to return to the Kite, a Gilead company Careers site #J-18808-Ljbffr$210.4k-272.3k yearly 2d agoProgram Integrity Data Scientist II
Caresource
Dayton, OH jobs
The Program Integrity Data Scientist II is responsible for developing, implementing, managing, and deploying in-depth analyses that meet the information needs associated with payment accuracy, anomaly detection, and Fraud, Waste, and Abuse (FWA). Essential Functions: Build concepts as algorithms that identify claims for pre- or post-pay intervention based on probability of fraud, waste, and abuse. Algorithms are implemented into production workflows for action: medical record request and audit, downcode adjustment, denial and remittance communication, etc. Analyze and quantify claim payment issues and provide recommendations to mitigate identified program integrity risks. Identify trends and patterns using standard corporate, processes, tools, reports and databases as well as leveraging other processes and data sources. Conduct outcome analyses to determine impact and effectiveness of corporate program and payment integrity initiatives. Collaborate on the examination and explanation of complex data relationships to answer questions identified either within the department or by other departments as it relates to payment accuracy, anomaly detection, and FWA. Monitoring of and providing explanation of anomalies related to trends associated with the potential for Fraud Waste and Abuse across the corporate enterprise. Collaborate with the Legal Department, generating data and analyses to support Legal proceedings. Develop hypothesis tests and extrapolations on statistically valid samples to establish outlier behavior patterns and potential recoupment. Create, maintain, and communicate an analytical plan for each project. Mine and analyze large structured and unstructured datasets. Employ wide range of data sources to develop algorithms for predicting risk and understanding drivers, detecting outliers, etc. Develop visualizations that demonstrate the efficacy of developed algorithms. Provide statistical validation and analysis of outcomes associated with clinical programs and interventions. Collaborate with other teams to integrate with existing solutions. Communicate results and ideas to key stakeholders. Prepare code for operationalization of end-to-end model pipeline and deliverable for business consumption. Perform any other job related duties as requested. Education and Experience: Bachelor's degree in Data Science, Mathematics, Statistics, Engineering, Computer Science, or a related field required Equivalent years of relevant work experience may be accepted in lieu of required education Three (3) years data analysis and/or analytic programming required Experience with cloud services (such as Azure, AWS or GCP) and modern data stack (such as Databricks or Snowflakes) preferred Healthcare experience required Competencies, Knowledge and Skills: Proficient in SQL and at least one of the following programming languages: Python / R / RAT STAT Familiarity with SAS is preferred Preferred beginner level of knowledge of developing reports or dashboards in Power BI or other business intelligence applications Ability to perform advanced statistical analyses and techniques including t-tests, ANOVAs, z-tests, statistical extrapolations, non-parametric significance testing, and sampling methodologies Working knowledge of predictive modeling and machine learning algorithms such as generalized linear models, non-linear supervised learning models, clustering, decision trees, dimensionality reduction and natural language processing Proficient in feature engineering techniques and exploratory data analysis Familiarity with optimization techniques and artificial intelligence methods Ability to analyze large quantities of information and identify patterns, irregularities, and deficiencies Knowledge of healthcare coding and billing processes, including CPT4, HCPCS, ICD-9, DRG and Revenue Codes preferred Proficient with MS office (Excel, PowerPoint, Word, Access) Demonstrated critical thinking, verbal communication, presentation and written communication skills Ability to work independently and within a cross-functional team environment Licensure and Certification:Working Conditions: General office environment; may be required to sit or stand for extended periods of time Up to 15% (occasional) travel to attend meetings, trainings, and conferences may be required Compensation Range: $83,000.00 - $132,800.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee's total well-being and offer a substantial and comprehensive total rewards package. Compensation Type: Salary Competencies: - Fostering a Collaborative Workplace Culture - Cultivate Partnerships - Develop Self and Others - Drive Execution - Influence Others - Pursue Personal Excellence - Understand the Business This is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds. #LI-GB1$83k-132.8k yearly 6d agoPrincipal Biostatistician
Edwards Lifesciences
Juneau, AK jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Montgomery, AL jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Irvine, CA jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. How you will make an impact: Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team Compile technical documents for internal and external audits Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection Lead the efforts of data analysis for data monitoring committee as needed What you'll need (Required): Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience What else we look for (Preferred): Training or publications in Bayesian methodology Expertise in MS Office (Word, PowerPoint, Access, Excel) Strong written/verbal communication and relationship management skills Up-to-date on statistical and regulatory developments Deep knowledge of clinical trial design, statistical modeling, and data analysis Proficient in SAS; experience with R, S-Plus Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices Excellent problem-solving, analytical, and critical thinking skills Proven leadership and ability to influence change Skilled in training/coaching and facilitating organizational change Detail-oriented; able to manage competing priorities in fast-paced environments Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly Auto-Apply 43d agoPrincipal Biostatistician
Edwards Lifesciences
Irvine, CA jobs
Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. How you will make an impact: Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team Compile technical documents for internal and external audits Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection Lead the efforts of data analysis for data monitoring committee as needed What you'll need (Required): Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience What else we look for (Preferred): Survival analysis experience Proven expertise in SAS Experience using other software packages (e.g., R, S-Plus) Statistical Analysis Plans (SAP) Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills Keeps abreast of new developments in statistics and regulatory guidance Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly Auto-Apply 10d agoPrincipal Biostatistician
Edwards Lifesciences Corp
Irvine, CA jobs
Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. How you will make an impact: * Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses * Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed * Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update * Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team * Compile technical documents for internal and external audits * Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) * Collaborate on developing case report forms and clinical database to ensure quality data collection * Lead the efforts of data analysis for data monitoring committee as needed What you'll need (Required): * Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience What else we look for (Preferred): * Survival analysis experience * Proven expertise in SAS * Experience using other software packages (e.g., R, S-Plus) * Statistical Analysis Plans (SAP) * Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel * Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills * Keeps abreast of new developments in statistics and regulatory guidance Extensive understanding and knowledge in statistical methodologies related to clinical trial designs, statistical modeling and data analyses * Extensive understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly Auto-Apply 9d agoPrincipal Biostatistician
Edwards Lifesciences
Little Rock, AR jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Sacramento, CA jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Washington, DC jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Denver, CO jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Hartford, CT jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Edwards Lifesciences
Phoenix, AZ jobs
Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $129,000 to $182,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. **COVID Vaccination Requirement** Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.$129k-182k yearly 42d agoPrincipal Biostatistician
Statistics & Data Corporation (SDC
Waltham, MA jobs
Job Description Principal Biostatistician Statistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning. Primary Responsibilities · Serve as an internal consultant for biostatistics analysis tools and methods. · Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support. · Actively support business development in capabilities presentations to prospective and current clients · Effectively manage assigned clinical study budgets for biostatistics analysis support. · Develop, coach and mentor junior biostatistics department personnel. · Act as the lead statistician on clinical research projects and help with SAS programming. · Provide statistical expertise for study design of clinical trial protocols. · Write statistical methods section of the study protocol, as needed. · Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed. · Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP) · Program summary tables, data listings and graphical representations of clinical trials data · Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data. · Prepare/review key sections of clinical study reports and various regulatory documents. · Perform statistical QC of all department outputs including analyses and clinical study reports. · Provide statistical support to answer questions from external clients (such as FDA, Investigators) · Contribute to the development, maintenance, and training of standard operating procedures (SOPs) · Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed. · Manage biostatistics timelines, budgets, and client expectations. · Adhere to all aspects of the Statistics & Data Corporation's quality system. · Comply with Statistics & Data Corporation's data integrity & business ethics requirements. · Perform other related duties incidental to the work described herein. · Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills · Effective leadership, budget forecast and implementation skills. · Excellent analytical skills, with the ability to process scientific and medical data. · Able to work independently and in teams. · Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills. · Excellent knowledge of statistical programming. · Expertise in manipulating and analyzing SAS data. · Able to identify data issues, present problems, and implement solutions. · Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients. · Excellent organizational and time management skills, with the ability to multi-task. · Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP). · Strong interpersonal communication and presentation skills. · Able to effectively collaborate across cross-functional teams. · Focus on quality at all times and in all situations. Education or Equivalent Experience · Typically a Master's degree in biostatistics, statistics or other related, scientific field and four years of relevant professional experience; or a PhD in biostatistics, statistics or other related, scientific field and three years of relevant experience; or equivalent combination of experience, education, and/or demonstrated ability. Benefits Why SDC SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry. •We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. •We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. •We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club. •We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. •With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team! #LI-Hybrid$104k-149k yearly est. 2d agoStatistician III
Penumbra
Remote
General SummaryUnder supervision of the Statistics Project Manager or higher, a Statistician III will analyze and interpret basic and advanced statistical analyses of clinical data accurately. The incumbent will understand all roles/tasks of a statistician in a clinical trial and identifies ways to proactively problem solve. This role will liaise with medical writers and study investigators in preparing research manuscripts for publication. Acts as a mentor to team members. Work You'll Do•Writes analysis plans and report specifications with minimal guidance. *•Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data. *•Uses statistical and medical understanding to propose and perform additional analyses appropriately.*•Demonstrates willingness and flexibility to try new statistical methods when analysis needs change. Keeps abreast of new statistical methods and techniques by attending conferences and workshops, opportunity permitting.•Seeks guidance for analyses appropriately.•Writes own SAS and/or R code, finds errors, corrects, and validates output and results.*•Considers alternative programming approaches to improve quality and/or efficiency.•Mentors less experienced programmer and/or statisticians.•Furthers programming skills independently.•Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.•Understands priorities and manages all project responsibilities independently. *•Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.*•Communicates appropriately with team members, external department or vendors, and supervisors on a regular basis.•Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group•Serves effectively on company-wide committees, opportunity permitting.•Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *•Perform other work-related duties as assigned. *Indicates an essential function of the role Position QualificationsMinimum education and experience:•PhD in Statistics, Biostatistics, Mathematics or related discipline or Master's degree with 4+ years of experience or Bachelor's degree plus 5+ years of experience in data analysis or equivalent combination of education and experience. Additional qualifications:•Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data. *•Uses statistical and medical understanding to propose and perform additional analyses appropriately.•Demonstrates willingness and flexibility to try new statistical methods when analysis needs change. Keeps abreast of new statistical methods and techniques by attending conferences and workshops, opportunity permitting.•Seeks guidance for analyses appropriately.•Writes own SAS and/or R code, finds errors, corrects, and validates output and results. *•Considers alternative programming approaches to improve quality and/or efficiency.•Mentors less experienced programmer and/or statisticians.•Furthers programming skills independently.•Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.•Understands priorities and manages all project responsibilities independently. *•Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.•Communicates appropriately with team members, external department or vendors, and supervisors on a regular basis.•Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group•Serves effectively on company-wide committees, opportunity permitting.•Ability to work effectively under tight timelines and schedules.•Ability to work independently and as a contributing team member.•Ability to determine methods and procedures on new assignments and may coordinate activities of other personnel.•Strong oral, written, and interpersonal communication skills•Proficiency with MS Word, Excel, and PowerPoint•Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously Working Conditions•General office, research laboratory, and hospital environments•Business travel to research laboratories, hospitals, conferences and or/ other Penumbra affiliated facilities from 0% - 50%•There is the potential for exposure to blood borne pathogens and other potentially infectious materials.•Requires some lifting and moving of up to 10 pounds•The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception. Annual Base Salary Range: $117,000 - $167,000This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range . We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.$117k-167k yearly Auto-Apply 2d agoSenior Statistician
Penumbra
Remote
General SummaryUnder general supervision of the Statistics Project Manager or higher, the Senior Statistician will perform methodology research and provide statistical expertise for the design, analysis, and reporting for assigned clinical studies. The Senior Statistician will conduct independent consultation across functional teams as needed. The incumbent may participate in planning meetings with strategic teams for purposes of identifying and communicating necessary statistical approaches to meet research and clinical trial objectives. The Senior Statistician will liaise with medical writers and study investigators in preparing research manuscripts for publication. Specific Duties and Responsibilities•Develops statistical methods and other relevant sections of major deliverables such as protocols, analysis plans, study reports and scientific publications. Prepare key sections of clinical study reports and various regulatory documents.* •Responsible for sample size estimation and justification.*•Responsible for randomization specifications using standard methodology. Develops complex randomization specifications with supervision.*•Works with external vendors to effectively implement the randomization schedule.•Support submission activities and documents, provide input on responses to regulatory authorities and other device development activities, as required. •Contribute to decision making on CRF data collection to ensure alignment with protocol objectives and statistical analyses defined in the protocol. •Actively participates in meetings to identify data collection instruments and database design requirements.•Author statistical analysis plans, including interim analysis and stopping rules, ensuring statistical methods and corresponding details are consistent with the study design, and sufficiently detailed for programming implementation including development of table and listing shells. Coordinate statistical analysis plans written by contractor or junior statisticians.*•Explain statistical concepts to non-statisticians to enhance their understanding of the analysis approach. Clearly communicate fundamental statistical concepts to statisticians and other personnel.•Summarizes and presents results (verbal and written) clearly, including creating reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.•Independently identifies issues arising in the design, conduct or analysis of clinical trials and proposes alternative analysis strategies or other recommendations to address these issues.•Uses statistical and medical understanding to propose and perform additional analyses appropriately.•Works collaboratively with multi-function teams to complete project deliverables per agreed timelines.•Ensures accuracy and internal consistency of report or publication, including text, tables, listings, and figures. Performs statistical QC for protocol, analysis plan, study report, and other major deliverables, including abstracts, oral and poster presentations and publications.* •Collaborates in publication of scientific research results in assigned areas. Works with project team to develop strategy for data presentation.•Identify and recommend corrections of flaws in scientific logic and statistical interpretation•Ensures consistency in presentation, inference, and adherence to accepted report guidelines and publication practices•Provides critical review to enhance quality of data presentation and scientific/statistical arguments•Participates in departmental activities including recruiting, training, mentoring, and cross-functional collaborations, as needed.•Maintains technical skills and increases own knowledge of new statistical methodology or areas of application through use of the scientific literature and by attending conferences and workshops, opportunity permitting.•Presents own statistical research or review of the statistical literature at meetings and seminars. •Demonstrates ability to act as a resource for other statisticians about a broad spectrum of analysis methods.•Possesses broad programming abilities and shares them with others by consultation and example.•Maintains programming skills even when delegating many programming tasks to others.•Able to guide, negotiate, and coordinate all statistical project responsibilities independently.*•Collaborates with project team members, including the project lead, investigators, statistical colleagues in manner that consistently demonstrates a high level of expertise, experience, and professionalism.•Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * •Ensure other members of the department follow the QMS, regulations, standards, and procedures.* •Perform other work-related duties as assigned. *Indicates an essential function of the role Position QualificationsMinimum education and experience:•Master's degree in Statistics, Biostatistics, Math or other scientific discipline with 6+ (six) years of experience or Bachelor's degree with 8+ years of experience in Clinical trial analysis in a medical device or pharmaceutical environment, or an equivalent combination of education and experience. Additional qualifications: •Competent in study design, descriptive and inferential statistics, clinical trial applications and computer programming.•Understanding of FDA regulatory requirements and ICH/GCP preferred.•High degree of accuracy, organizational skills and attention to detail are essential.•Experience analyzing complex study objectives and developing appropriate analysis specifications and plans. •Exercising judgment in selecting methods, techniques, and evaluation criteria for obtaining results. •Builds strong relationships with peers and cross functionally with partners outside of team Experience writing statistical analysis plan (SAP) from the clinical protocol and other study specific documents. •Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.•Able to work under time pressure and handle multiple tasks simultaneously.•Determines methods and procedures on new assignments and may coordinate activities of other personnel. Strong interpersonal, collaborative and communication skills are required. Annual Base Salary Range: $127,000 - $207,000This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range . We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. What We Offer•A collaborative teamwork environment where learning is constant, and performance is rewarded.•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.•A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s). Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws. If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents. For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.$127k-207k yearly Auto-Apply 13d agoPrincipal Biostatistician
Neurocrine Biosciences
San Diego, CA jobs
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role:Serves as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research. Leads statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility. _ Your Contributions (include, but are not limited to): Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies Represents Biometrics on one or more Dev Core Team or clinical subteam (as appropriate for the clinical program) Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies Reviews and approves clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements Prepares, reviews, and approves statistical analysis plans Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company as needed, including consulting and statistical analysis Assists in the development of department standard operating procedures and statistical analysis plan and report templates, data standards, and selection and implementation of statistical software Mentors junior members of the biostatistics team and supervises their work on an as-needed basis Researches, identifies, develops, and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s) Performs other duties as assigned Requirements: Master's degree in statistics or biostatistics, or a related discipline and 4+ years of experience in the design, analysis, and reporting of clinical studies. Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data. Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets. Proven interaction directly with regulatory authorities highly desirable. OR PhD in statistics or biostatistics, or a related discipline preferred and 2+ years of related experience Demonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activities Strong organizational skills and proven ability to effectively lead a project to successful completion Significant expertise in the design, analysis, and reporting of clinical studies Advanced knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data Advanced knowledge of working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data Expertise in interacting directly with regulatory authorities highly desirable Maintains expertise in state-of-the-art data manipulation and statistical analyses Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines Works to improve tools and processes within functional area Developing reputation inside the company as it relates to area of expertise Ability to work as part of and lead multiple teams Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams Excellent computer skills Excellent communications, problem-solving, analytical thinking skills Sees broader picture, impact on multiple departments/divisions Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management skills #LI-QH1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $130,800.00-$179,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.$130.8k-179k yearly Auto-Apply 35d agoStatistician (PhD)
Ann & Robert H. Lurie Children's Hospital of Chicago
North Chicago, IL jobs
Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Simpson Querrey Biomedical Research Center Collaborates with researchers to develop and deliver statistical analyses, datasets, statistical process control charts and other data products for research studies and grant proposals. Serves as an expert on biostatistics and epidemiology for the Stanley Manne Children's Research Institute; develops and submits statistical/methods sections for grant applications; and writes statistical/methods and findings sections of scientific papers. Guides Manne Research Institute and Data Analytics and Reporting (DAR) master's trained statisticians in complex analytic projects. Takes ownership of project plans, including estimation of task durations, documentation and communication of risks, dependencies and constraints, and tracking of issues impacting project completion. Independent statistical research and faculty appointment will be considered based on background, experience, and interest. "Please note that a completed Doctorate degree is a minimum requirement to be considered for this role." Essential Job Functions: Provides statistical support to interdisciplinary research programs across the research institute. Advises and guides researchers and DAR analysts in statistical methodologies. Conducts in-services and other training to advance the skill sets of researchers and DAR analysts. Write statistical/methodology sections of grant proposals or reviews these for accuracy. Write statistical/methods/findings sections of scientific papers. Writes analytic and statistical programs, routines and stored processes to transform extracts into tables and figures, or other data summaries, visualizations and dashboards using SAS or equivalent statistical software and Microsoft tools (SSRS, Power Pivot, Power Query, Power BI). Records and refines data requirements related to projects on the measurement and monitoring of research projects and workflow processes. Writes programs and scripts that convert customer requirements into data extracts, making use of Epic Clarity, Epic Cogito data warehouse, Crystal Reports, SQL, and/or SAS statistical software. Facilitates the validation of database/data warehouse extracts to ensure that results correspond to what is recorded in the transactional application (i.e., Epic Hyperspace). Adheres to HIPAA regulations for privacy, transactions, security and confidentiality; follows procedures to ensure data release restrictions related to service area and/or IRB approved elements are maintained. Performs other job duties as assigned. Knowledge, Skills and Abilities: Doctoral degree in biostatistics, epidemiology or healthcare-related statistics is required. Minimum five (5) years of experience in biostatistics, epidemiology, health services research, econometrics, OR psychometrics within healthcare. Demonstrated expertise in mentoring master's trained statisticians, junior medical faculty, residents, or fellows, and with teaching complex methodologies in a classroom-like setting. Demonstrated experience in grant writing and writing for the academic literature. A minimum of five (5) years of experience programming SAS statistical software (or equivalent), including at least one (1) year of experience writing SQL queries and implementing basic techniques to improve efficiency. Prior experience extracting or analyzing Epic electronic medical record data preferred. Ability to work independently while being an essential part of a team. Education Reference job description (Required) Pay Range $93,600.00-$154,440.00 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints - recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************$93.6k-154.4k yearly Auto-Apply 60d+ agoStatistician
Mayo Healthcare
Rochester, MN jobs
The Biostatistician functions as a statistical consultant/project manager by applying statistical programming and related methods such as machine learning and scientific expertise to the design, implementation, analysis, interpretation, and reporting of research, clinical, and administrative studies. The Biostatistician must possess basic expertise in a wide variety of statistical techniques to meet the demands of study teams and investigators. The Biostatistician will assist with directing the progress of the biostatistical aspects of research and clinical studies, in collaboration with consulting staff or a higher-level Biostatistician. The Biostatistician will work with senior-level Biostatisticians to summarize and communicate project findings to study team members, investigators, journal and grant reviewers, committees, and other individuals and entities as needed. The Biostatistician may work independently with limited oversight from higher-level Biostatisticians in some situations. This vacancy is not eligible for sponsorship/ we will not sponsor or transfer visas for this position. Also, Mayo Clinic DOES NOT participate in the F-1 STEM OPT extension program. Master degree in Statistics, Biostatistics or equivalent. Alternatively, a master degree in Mathematics, Public Health or Data Science with at least 12 graduate level semester hours in statistics, biostatistics or equivalent. Experience in statistical analysis and programming software such as SAS, R or python. Applicable skills include organization, documentation, written and oral communication. A commitment to customer service with an attitude of owning the experience of each customer is required. Other beneficial attributes include logical and systematic thinking, basic knowledge of human physiology and/or medical terminology, and inquisitiveness. Prefer graduate GPA of 3.0 or greater.$49k-68k yearly est. Auto-Apply 8d agoStatistician (PhD)
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, IL jobs
Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Simpson Querrey Biomedical Research Center Collaborates with researchers to develop and deliver statistical analyses, datasets, statistical process control charts and other data products for research studies and grant proposals. Serves as an expert on biostatistics and epidemiology for the Stanley Manne Children's Research Institute; develops and submits statistical/methods sections for grant applications; and writes statistical/methods and findings sections of scientific papers. Guides Manne Research Institute and Data Analytics and Reporting (DAR) master's trained statisticians in complex analytic projects. Takes ownership of project plans, including estimation of task durations, documentation and communication of risks, dependencies and constraints, and tracking of issues impacting project completion. Independent statistical research and faculty appointment will be considered based on background, experience, and interest. "Please note that a completed Doctorate degree is a minimum requirement to be considered for this role." Essential Job Functions: Provides statistical support to interdisciplinary research programs across the research institute. Advises and guides researchers and DAR analysts in statistical methodologies. Conducts in-services and other training to advance the skill sets of researchers and DAR analysts. Write statistical/methodology sections of grant proposals or reviews these for accuracy. Write statistical/methods/findings sections of scientific papers. Writes analytic and statistical programs, routines and stored processes to transform extracts into tables and figures, or other data summaries, visualizations and dashboards using SAS or equivalent statistical software and Microsoft tools (SSRS, Power Pivot, Power Query, Power BI). Records and refines data requirements related to projects on the measurement and monitoring of research projects and workflow processes. Writes programs and scripts that convert customer requirements into data extracts, making use of Epic Clarity, Epic Cogito data warehouse, Crystal Reports, SQL, and/or SAS statistical software. Facilitates the validation of database/data warehouse extracts to ensure that results correspond to what is recorded in the transactional application (i.e., Epic Hyperspace). Adheres to HIPAA regulations for privacy, transactions, security and confidentiality; follows procedures to ensure data release restrictions related to service area and/or IRB approved elements are maintained. Performs other job duties as assigned. Knowledge, Skills and Abilities: Doctoral degree in biostatistics, epidemiology or healthcare-related statistics is required. Minimum five (5) years of experience in biostatistics, epidemiology, health services research, econometrics, OR psychometrics within healthcare. Demonstrated expertise in mentoring master's trained statisticians, junior medical faculty, residents, or fellows, and with teaching complex methodologies in a classroom-like setting. Demonstrated experience in grant writing and writing for the academic literature. A minimum of five (5) years of experience programming SAS statistical software (or equivalent), including at least one (1) year of experience writing SQL queries and implementing basic techniques to improve efficiency. Prior experience extracting or analyzing Epic electronic medical record data preferred. Ability to work independently while being an essential part of a team. Education Reference job description (Required) Pay Range $93,600.00-$154,440.00 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints - recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************$93.6k-154.4k yearly Auto-Apply 60d+ ago
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