Biostatistics director work from home jobs

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. Our mission is powered by our people. Our core values - be audacious, be curious, be authentic, be engaged, and be accountable - create a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and determination, we encourage you to read the opportunity below and apply. THE OPPORTUNITY Amylyx is seeking an experienced and motivated Director of Biostatistics. In this role you will liaise with various internal and external stakeholders (e.g. Clinical Development, Regulatory, Pharmacovigilance, Translational Sciences, Programming and Data Management, CROs) for the implementation of a clinical development program, regulatory submissions and post-submission strategies/preparation/defense. RESPONSIBILITIES Provide strategic leadership of statistical approaches on an assigned therapeutic area or a program, shaping clinical development plans from early design through regulatory submission, and serving as a statistical thought partner to cross-functional leaders and external stakeholders. Design and oversee implementation of robust, innovative trial designs that maximize probability of clinical and regulatory success, balancing scientific rigor with operational feasibility, while anticipating and proactively addressing potential regulatory challenges. Mentor, coach, and develop statisticians at varying levels of experience by providing technical guidance, fostering professional growth, and instilling best practices in statistical methods, data integrity, and regulatory compliance. Synthesize and present statistical insights by preparing data packages and cross-functional presentations, effectively communicating strategies, assumptions, and implications to leadership, regulatory bodies, and scientific audiences. Partner closely across functions to ensure alignment, collaboration, and timely execution of statistical deliverables that enable high-quality program success. Engage in occasional travel (Cambridge, MA and other locations) for collaboration and conferences, typically at least three times annually. REQUIRED QUALIFICATIONS PhD in Statistics/Biostatistics, Mathematics, or related quantitative fields with a minimum of 10 years, or MSc with a minimum of 14 years of experience with clinical trials including late-phase studies. Proficiency in scientific computing/programming (SAS or R) and implementation of advanced statistical analyses and simulations, deep knowledge of CDISC standards. Proficiency in the design of clinical trials Phases I - III, in applying knowledge of general and cutting edge statistical / clinical trials methodologies to solve complex statistical problems in the clinical development programs and to ensure alignment with regulatory agencies and industry standards. Demonstrate skills in the analysis and reporting of clinical trials; experience with integrated summaries of safety and efficacy (ISS and ISE). Prior experience in interactions with regulatory and health authorities considered a plus. WORK LOCATION AND CONDITIONS At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii Michigan and Tennessee. You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location. Compensation The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity. Estimated Pay Range$213,000-$240,000 USD To stay connected with us follow Amylyx Pharmaceuticals on LinkedIn. To return to our website please click here. Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities: Strategic Statistical Leadership * Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. * Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). * Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership * Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: * Clinical trial biostatisticians * Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) * Medical Affairs statisticians * Statistical programmers * Biomarker/statistical genetics experts in oncology * RWE analysts/statistical epidemiologists * Safety/PV statisticians * Advanced analytics and modeling specialists * Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement * Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). * Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. * Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence * Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. * Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. * Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development * Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. * Share knowledge and best practices across study teams and therapeutic areas. * Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence * Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. * Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. * Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

We are hiring for an Associate Director / Director, Biostatistics This role is located in Washington, DC and is fully onsite. Our client is seeking a highly experienced Associate Director / Director of Biostatistics to lead statistical strategy and execution across their clinical development programs. This is a key leadership role with broad influence on study design, data integrity, regulatory submissions, and the growth of the Biostatistics function. In this role you will: • Serve as the lead statistician for multiple clinical studies across diverse therapeutic areas • Drive clinical trial design, protocol development, and creation of robust Statistical Analysis Plans (SAPs) • Lead data analysis, TFL generation, interim analyses, and integrated summaries of efficacy and safety • Provide strategic statistical consultation and collaborate closely with clinical, medical, regulatory, and data teams • Manage internal statisticians, contract resources, programming teams, and CRO biostatistics support • Represent Biostatistics in cross-functional project and study team meetings • Support regulatory interactions, responses, and submission-related activities • Identify potential statistical risks, propose solutions, and bring in external experts as needed Requirements: • PhD in Biostatistics or Statistics • 5+ years of clinical trial experience (pharmaceutical or CRO) • Deep knowledge of clinical trial methodology, ICH/GCP, and regulatory expectations • Strong, hands-on experience with SAS and R / S • Exceptional communication, leadership, and organizational skills • Ability to collaborate effectively in a dynamic, fast-paced environment Here you'll have the opportunity to influence clinical development at a strategic level, mentor talented statisticians, and contribute to meaningful innovations that impact patient lives. Salary - $175k-240k base + bonus Fantastic benefits package including equity and unlimited PTO If you are interested or know someone who might be, please reach out to me at **************************!

Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. Affiliate Overview Eidos Therapeutics, an affiliate within BridgeBio Pharma, is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You'll Do The Associate Director, Biostatistics is responsible for statistical activities in support of Medical Affairs activities, including contributing to providing scientific and methodological expertise to support medical strategy, publications, and external engagements. This role will focus on the design, execution, interpretation, and communication of analyses that inform medical decision-making, health outcomes, and scientific exchange. A successful candidate will also interact with internal and external cross-functional study teams, supporting interactions with the medical community, and manage contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Responsibilities Provide statistical input to medical publications, scientific congresses, and external collaborations Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management Ensure high-quality statistical deliverables that meet scientific and regulatory standards Partner with colleagues in Medical Affairs, HEOR, Clinical Development, and other cross-functional teams to align statistical activities Translate statistical concepts into clear insights for medical and scientific stakeholders Stay current with evolving statistical methods, data sources, and regulatory expectations related to real-world evidence CRO / Vendor Oversight: Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide the CRO biostatistician and statistical programmers. Ensures deliverables are accurate and delivered according to the timelines Where You'll Work This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office. Who You Are PhD or Master's degree in Biostatistics, Statistics, or related field 7+ years (PhD) or 10+ years (Master's) of biostatistics experience in the pharmaceutical/biotech industry Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences Excellent programming skills in SAS and/or R Ability to work as a part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors Experience contributing to medical publications and scientific communications preferred Familiarity with HEOR and real-world evidence analysis preferred Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Financial Benefits: Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Pre-tax commuter benefits Referral program with $2,500 award for hired referrals Health & Wellbeing: Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office Skill Development & Career Paths: People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary$195,000-$230,000 USD

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: Reporting to the Executive Director, Biostatistics, this position is responsible for collaborating with both internal and external stakeholders to deliver the execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup. Key Responsibilities: Provide statistical inputs into protocol and clinical study report development, statistical analysis plans, interpretation of statistical analysis results, randomization plans. Provide oversight and review of statistical documents for multiple clinical trials, including TLF shells, eCRFs, specifications of variable derivations, and all deliverables from outside vendors or internal programmers. Develop effective collaborations with others within clinical teams and partner lines (such as Statistical Programming, Data Management, Medical, Clinical Operations, and Regulatory). Ensure that all study level statistical activities are conducted in compliance with relevant regulatory requirements and Immunovant standards. Provide planning, delivery and communication of statistical analyses, data presentations, and scientific reports. Oversight statistics and programming vendors. Open to opportunities to utilize innovative statistical methodology to streamline the clinical development process and facilitate optimal decision-making. Requirements: PhD or MS in Statistic, Biostatistics, Mathematics, or related field 5+ years (7+ years for MS) of experience in biotechnology, pharmaceutical or health related area Knowledge of relevant FDA, EU, ICH guidelines and regulations Understanding of drug development Demonstrated ability to collaborate with diverse sets of stakeholders Strong written and oral communication skills with attention to detail Desire to work in a fast-paced, innovative environment Natural collaborator who enjoys working on a cross-functional team Work Environment: Remote-based; access to Immunovant's NYC and North Carolina offices available Dynamic, interactive, fast-paced, and entrepreneurial environment Domestic or international travel may be required ( Salary range for posting$190,000-$210,000 USD Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

This is an exciting opportunity to lead a team of statisticians advancing adoption of Natera's oncology portfolio of cutting-edge molecular diagnostic tests. As an Associate Director in Biostatistics, you will leverage your deep applied statistics and leadership background to guide the design and interpretation of Natera sponsored clinical studies ensuring scientific rigor and meaningful clinical insights across oncology programs. This position will play a central role in defining the team's vision, fostering excellence in biostatistics deliverables, and cultivating a high-performing, collaborative environment that drives long-term success. PRIMARY RESPONSIBILITIES: Direct a team of biostatisticians, taking responsibility for their individual deliverables and growth (technical and professional) Oversee Biostatistics contributions to oncology product clinical validation projects Lead development of novel statistical approaches and simulations to support innovative study designs. Produce, review, and standardize high-quality documentation for cross-functional internal and external collaborators and stakeholders Identify risks, communicate concerns, and champion solutions to cross-functional project teams Continuously improve the efficiency and efficacy of team through innovative techniques and strategies Manage contracts and deliverables provided by CROs as needed. QUALIFICATIONS: Advanced degree (Ph.D. or M.S.) in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred) 7+ years of experience in clinical trial biostatistics Strong knowledge of survival analysis, censoring, and other advanced statistical techniques relevant to oncology Expertise with study design innovation and power/simulation approaches Proven track record in mentoring and developing junior staff Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences and foster collaborative, cross-functional partnerships KNOWLEDGE, SKILLS, AND ABILITIES: Strong technical leadership and strategic thinking. Proven success leading and developing teams. Deep expertise in statistical methods for diagnostics and clinical trials, including FDA requirements. Effective collaborator across diverse technical disciplines. Clear, high-quality scientific and technical communication. Familiarity with NGS, ct DNA, and molecular oncology preferred. The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations.Remote USA$174,400-$218,000 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cf DNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit *************** Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: ********************************************************************** Please be advised that Natera will reach out to candidates with ************* email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - BBB announcement on job scams - FBI Cyber Crime resource page

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: Friendly, open, and fun team culture that values unique perspectives Company-wide dedication to profoundly impacting patients' lives Comprehensive, high-quality benefits package effective on date of hire Educational assistance available for all employees Matching 401(k) retirement plan Paid holidays, including floating holidays, to be used at your discretion Employee Stock Purchase Plan Referral incentive program Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Biostatistician The Biostatistician is responsible for the design and conduct of clinical research studies including developing statistical analysis plans, performing basic and complex statistical analysis, interpretation and reporting of study results and other required activities as needed. Responsibilities include providing data analysis input to meet project objectives, contributing to statistical analysis sections of IRB and grant applications, developing and executing statistical programs to perform analyses and prepare data displays, drafting analysis and results sections for clinical study reports and scientific papers, and supporting general publication of study findings. Requirements of the Biostatistician A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years' relevant experience or a master's degree plus 8 years' relevant experience with demonstrated ability and sustained performance at the Ph.D. level. Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry Demonstrated success in delivering on goals and being part of fast-moving, collaborative team Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development Must demonstrate strong interpersonal, written, and oral communication skills across various levels of management and demonstrate the ability to manage differences and needs between multiple stakeholders Responsibilities of the Biostatistician The specific duties of the Biostatistician include but are not limited to: Leadership and Project Management: Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. Apply project management skills, statistical and programming techniques, and achieve quality and on time delivery of deliverables. Coordinate activities with project/program overall management personnel to achieve program objectives. Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs. Statistical Planning and Methodologies: Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects. Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. Write Statistical Analysis Plans (SAPs) and properly address quality control (QC) review comments. Create and maintain Statistical and Programming QC and QA Plans for assigned projects or programs. Provide input to unblinded data management plan when required. Participate or lead research and development of statistical methodologies and processes. Lead efforts in planning, researching and designing statistical methods and approaches in solving complex trial data analysis and operational issues. Statistical Programming: Develop and/or review ADaM and/or SDTM dataset specifications. Lead efforts in resolving complex data derivation and data handling issues. Perform statistical programming to either build analysis datasets and generate statistical tables, listings and graphs (TLGs) or perform QC validation of these datasets and TLGs. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. Review and provide input to Data Standards Review comments to ensure quality of documents. Perform QC programmatic checks on core study results as well as overall quality/consistency review of statistical TLGs. Statistical Analysis and Reporting, Publication Support: Perform complex statistical modeling and analyses, implement new statistical analysis methods and strategies. Perform statistical analysis as per SAP, and address peer/QC review comments and findings. Perform statistical validation of core results, address additional QC validation comments and findings on the core results. Plan and conduct or contribute to the trial results reporting. Contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. Write statistical report or statistical sections of the CSR, or perform peer review of the contents. Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. Supporting Clinical Data Collection and Cleaning: Provide statistical input to Case Report Forms (CRF) design and database/variable structure. Provide statistical input to non-CRF data collection and acquisition methods and approaches. Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. Perform ongoing assessment and communication of data quality issues, including protocol deviations. Assist data management and trial management team in preparing for database lock. Perform other duties as directed by the Supervisor Location Remote OR 111 West Oak Ave., Tampa, FL 33602 #LI-AC1 #LI-REMOTE Benefits/Compensation This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions. Salary Range$122,386-$152,982 USD Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Biostatisticians for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Key Accountabilities: 1. Leadership and Project Management: Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations. Lead assigned projects by applying project management skills, statistical and programming techniques; achieve quality and on time delivery of deliverables, earn client's trust and repeat business. 2. Statistical Planning and Methodologies: Provide statistical expertise for design, analysis and reporting of clinical trials and research projects. Contribute to the writing of statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes. Write Statistical Analysis Plans (SAPs) and properly address Peer Statistician review comments. Create and maintain Statistical and Programming Quality Control (QC) and QA Plans for assigned projects. Provide input to unblinded data management plan when required. Assist in research and development of statistical methodologies and processes. 3. Statistical Programming: Develop and/or review ADaM dataset specifications. Review and provide input to SDTM dataset specifications when required. Perform QC validation of analysis datasets and TLGs. Perform third level review of dry runs and final run. Lead statistical dry runs and final run by actively participating or contributing to project and resources management, addressing statistical and programming questions and interacting with data management to follow up and resolve data issues. Review and provide input to the Analysis Data Reviewer's Guide, discuss and incorporate Data Standards Reviewer's review comments to ensure quality of the document. 4. Statistical Analysis and Reporting, and Publication Support: Perform statistical analysis as per SAP, and address peer/QC review comments and findings. Perform statistical validation of core results, address additional QC validation comments and findings on the core results. Plan and conduct or contribute to the trial results reporting/dissemination meetings. Under supervision contribute to the contents describing any deviation from the planned analysis and deviation from study conduct for the Clinical Study Report (CSR). Review CSR to ensure accuracy, completeness and appropriateness of the interpretation of the statistical results. Write statistical report or statistical sections of the CSR. Perform statistical analyses for publications, including but not limited to abstracts, manuscripts, presentations and posters. 5. Supporting Clinical Data Collection and Cleaning: Provide statistical input to Case Report Forms (CRF) design and database/variable structure. Provide statistical input to non-CRF data collection and acquisition methods and approaches. Review Data Management Plan sections relating to critical data collection and cleaning. Provide statistical input to Data Validation Specification. Specify and/or program database quality acceptance checks, assess and report data quality issues, and follow through until resolution. Perform ongoing assessment and communication of data quality issues, including protocol deviations. Assist data management and trial management team in preparing for database lock. 6. Complete job required and project-specific training. Comply with applicable Everest and trial sponsor's policies, SOPs, and work instructions. 7. Properly archive study files in accordance with trial sponsor's requirements. 8. Plan and carry out professional development activities. Qualifications and Experience: A Ph.D. degree in statistical science, mathematical analysis or related fields plus 2 years highly relevant experience or a Master's degree plus 4 years highly relevant experience, with demonstrated ability and sustained performance. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ***************** Estimated Salary Range: $130,000 - $160,000. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-TK1 #INDHP

The Principal Biostatistician provides statistical input into Phase I - IV clinical trial development, performs the analysis of clinical trial data, and provides statistical input into the reporting of clinical trial results. The Principal Biostatistician can work independently and function as a lead statistician on clinical trials. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture - 70% remote workforce, 66% women-led teams Learn more about our core values here! What we offer: Benefits vary by location and may include: Remote working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for: • PhD degree in Statistics, Biostatistics, or related field, and 5 years of biostatistical experience in the clinical trials or health research environment OR a Master's degree in Statistics, Biostatistics, or related field, and 8 years of biostatistical experience in the clinical trials or health research environment. • Excellent written and oral communication skills including grammatical/technical writing skills and familiarity with moderately complex statistical methods that apply to Phase IIV clinical trials are required. • Familiarity with SAS, SPSS or other statistical software package. • Proficiency in Microsoft Word and Excel. • Strong level of detail orientation. • Ability to work on multiple tasks under tight timelines. Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. #LI-SI1 Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. **Location** : United States - Remote **Key Accountabilities** : **Operational Execution** + Provide broad statistical support, including trial design, protocol and CRF development on specific studies + Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents + Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols + Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans + Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review **Business Development** + Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings **General Activities** + Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis + Understand, apply and provide training in extremely advanced and sometimes novel statistical methods + Contribute to the development and delivery of internal and external statistical training seminars and courses + Review position papers based on current good statistical practice + Interact with clients and regulatory authorities + Review publications and clinical study reports + Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) + Additional responsibilities as defined by supervisor/manager. **Skills:** + Good analytical skills + Good project management skills + Professional attitude + Attention to detail + Thorough understanding of statistical issues in clinical trials + Ability to clearly describe advanced statistical techniques and interpret results + Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines) + Prior experience with SAS programming required + Ability to work independently + Good mentoring/leadership skills + Good business awareness/ business development **Knowledge and Experience** : + PhD or MS in Statistics or related discipline with substantial experience + The knowledge of pharmacokinetic data is an advantage + Competent in written and oral English in addition to local language **Education:** + PhD in Statistics or related discipline, MS in Statistics or related discipline \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

As an experienced Principal Biostatistician in our sponsor-dedicated Flexible Solutions business unit, you are central to the successful delivery of complex clinical trials for renowned, innovative and global top pharmaceutical and biotech companies. In this role you will develop and review Statistical Analysis Plans for data presentation, analyses, and provide programming support to your multidisciplinary global project team. About the team You will be part of a long-lasting partnership with one of our top sponsors (a 10-years relationship) for which we pride ourselves on being the preferred provider. In this team, you will work with over 150 people globally, all with great experience and ready to support you at any given time since we work globally from the US to APAC. What else can you expect from us? Rewarding and meaningful work in an established, diverse, highly profitable and respected global company Highly competitive compensation packages, including various local benefits such as pension contributions, complimentary health insurance plans, remote working allowances etc. A genuine work life balance Flexibility in working hours A thorough onboarding with support from your personal mentor Excellent training and career development opportunities, as well as support with advancing your individual education Strong support from your Fortrea Line Manager and your team, as well as from more than 19,000 colleagues worldwide Your responsibilities: Lead complex studies such as New Drug Applications submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings Perform project management activities for identified projects including resource planning, timelines and milestone management Serve as Data Monitoring Committee Support Statistician, developing DMC Charters and attending DMC Meetings, under direction of Statistical Consultants Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians Conduct overall statistical review of Tables Figures and Listings for complex studies prior to client delivery Review Case Report Form and other study specific specifications and plans Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant Preparation and review of randomization specifications and generation of randomization schedules Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures Present and share knowledge at monthly seminars and/or team meetings and at external scientific meetings and conferences Attend bid defense meetings for complex studies Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives Represent the department during audits. Your profile: Degree in a relevant field such as statistics, biostatistics, public health, etc. Masters degree strongly preferred. Solid experience (10+ years) of working as a Lead Biostatistician in either a biotech, CRO or pharmaceutical company Ability to program in one or more statistical software packages (SAS ) used to conduct statistical analyses; SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis Proven professional experience with SDTMs, ADaM datasets and TFLs Proven ability to effectively communicate statistical concepts A good knowledge of the overall clinical trial process Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc. across a variety of trials Strong organizational skills, an autonomous and collaborative work style, a curious mind and a keen attention to detail Business fluency in English - both verbal and written - is a must Physical Demands/Work Environment: Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: Frequently stationary for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Pay Range: $130,000-$150,000 USD base annual salary (US Candidates only) Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. The application deadline is December 15, 2025. #LI-REMOTE #LI-LL1 Learn more about our EEO & Accommodations request here.

The Biostatistician will work with health system research teams to manage datasets, design studies, form analysis plans, and perform sample size/power calculations and stratification/randomization of studies, statistical programming, data management, analysis and report writing. Additionally, will provide consultation on the design of data processing systems, specifying the needed output, the required input and the methods of validation and quality control. Will recommend and carry out effective statistical methodology and strategies necessary for the creation, completion, and analysis of research projects and supervises the planning and designing of analytical procedures by others as requested. Will recommend the most appropriate analytical design for a broad range of data and analyze data using the most appropriate statistical procedures for the evaluation of outcomes studies. The biostatistician will support the preparation of peer-reviewed publications and will serve as primary and/or co-author on publications. Incumbent will also contribute as a statistical reviewer and editor for other manuscripts produced by the professional staff. The biostatistician will provide technical leadership, consultation, and advice on statistical analysis, methods and techniques for epidemiologic or research studies. Estimated salary range for this position is $93867.22 - $122027.39 / year depending on experience. Degrees: * Doctorate. Licenses & Certifications: * Collab Inst Training Init. Additional Qualifications: * PhD in Biostatistics/Epidemiology, Statistics, Health Economics, or another relevant field. * Expert technical abilities in statistical methodologies and knowledge of outcomes research and clinical methodologies, cost effective analysis, ability to analyze complex genetic data with cutting edge statistical methods, and generating risk scores based on large available variables. * Skilled in data manipulation and linkage of large datasets. * Knowledge of computer software systems appropriate for data analysis like SAS or STATA. * Manipulation of large datasets. * Experience in using hospital administrative databases or large claim databases and familiar with medical coding (DRG, ICD, HCPC, CPT, NDC) would be desirable. * Experience in publication (abstract, poster, manuscript) preparation process. * Ability to work on multiple projects with competing priorities. * Excellent interpersonal, communication, problem solving, and analytical skills. Minimum Required Experience: 5 Years

Job Details Main Corporate Office - Malvern, PADescription Job Purpose: The Principal Biostatistician is a key member of Ocugen's clinical development team. This individual will be responsible for providing statistical services including analysis, interpretation, design, and reporting or communication of data evidence for research, development, and/or marketed product. The individual should be able to ensure application of appropriate statistical methods given the hypothesis and available data through programming in SAS, or R. This individual will work closely with the Director of Biostatistics, the rest of the team at Ocugen, and CROs to execute the statistical and data needs of the clinical studies. Duties and Responsibilities: Collaborates on implementation and analysis of statistical aspects of research protocols. Provides statistical consultation for clinical programs. Performs sample size and power calculations, and provides input on Study Protocols. Develops statistical analysis plans, including detailed textual description of planned analysis and mock-ups of data displays. Assists in development of CRFs, programming specifications, and additional study documents related to data flow and analyses. Performs statistical analyses, including hypothesis testing and modeling. Provides tabular and written summaries of analyses and statistical methodology. Reviews and provides comments on statistical summaries. Interface with CRO ensuring data and statistical reporting is secure and timely. Provides input to project timelines, and ensures that project timelines for biostatistics deliverables are met. Ensures that project tasks are completed with acceptable quality. Attends team meetings and represents departmental needs for assigned projects. Participate in study and department meetings. May assist in developing policies and procedures (SOPs). Additional tasks and projects as requested. Qualifications MS/MA degree in Biostatistics. 5+ years of research experience working as Biostatistician, or Statistical Programmer Ability to synthesize results in graphic, oral, and written reports Exceptionally strong statistical programming in SAS Experience programming in other languages, such as R, SQL, Matlab Strong knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies Demonstrated attention to detail and outstanding organization skills Self-motivated with a commitment to high quality, on-time deliverables Excellent communication and collaboration skills with a team-oriented approach Demonstrated ability to identify and resolve issues and effectively manage timelines Working Conditions: This position operates in an office setting, in person. Remote work will be limited. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. Physical Requirements: This is a largely sedentary role. Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual's conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary The Senior Biostatistician carries out tasks assigned within the timelines and the standards of quality, while providing supervision to biostatisticians, preparing Statistical Analysis Plans and writing the statistical methodology and results sections of reports. The Senior Biostatistician provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings of other staff and clients on statistical methodology and statistical principles. Job Description THE SENIOR BIOSTATISTICIAN ROLE The Senior Biostatistician carries out tasks assigned within the timelines and the standards of quality, while providing supervision to biostatisticians, preparing Statistical Analysis Plans and writing the statistical methodology and results sections of reports. The Senior Biostatistician provides statistical input to the design and review of Protocols and Case Report Forms and prepares and performs trainings of other staff and clients on statistical methodology and statistical principles. ESSENTIAL JOB FUNCTIONS* Writes and reviews the statistical methodology and results sections of reports Review of Statistical analysis (tables, figures and listings) and specifications of clinical trials Performs sample size calculation Writes Blind Review plans and reports Writes and review statistical parts of scientific articles Prepares and reviews Statistical Analysis Plans Advises other staff and clients on statistical methodology and statistical principles. Participates and conducts Blind Review meeting. Supports the presentations to clients and manages the technical communications with client when assigned as lead statistician to a study Create SAS and/or R programs for Datasets and TLFs validation Prepares and performs training to internal/external staff on statistical methodology and statistical principles Provides statistical input to the design and review of Protocols and Case Report Forms Participates to DMC/DSMB meetings Provides support to DMC/DSMB charter preparation Reviews the specifications for analysis datasets Conducts other activities as required PREPARATION, KNOWLEDGE, SKILLS & ABILITIES Master's degree in Statistics At least 3 years of experience in Biostatistics SAS Programming, Good R Programming, Basic/Good Broad Range of Statistical methodology skills, Very Good ICH E9 Statistical Principles for Clinical Trials, Very Good English, Good MS Office Suite, Good Professional Trustworthy Ability to effectively prioritize Quality focused Personable Attitude Willingness to learn Team Player Effective Stress Management Techniques Learning Agility Ability to Manage Conflict Problem Solving Skills Effective Verbal Communication Skills Commercial and Technical Writing Skills Networking Skills Languages English Education Bachelor of Arts (BA): Statistics Contract Type Regular

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at *************** Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Senior Statistical Analyst is a key role in the research and development of new pharmaceutical products. The primary responsibilities for this role include the analysis and reporting of clinical trial data and leading the statistical programming activities for clinical studies and projects with lower complexity. The Senior Statistical Analyst interfaces with Statistics, Data Sciences, Medical Writing, Regulatory Publishing and Clinical Operations. Responsibilities: Leads the statistical programming activities for projects with lower complexity. Leads the statistical programming activities for studies. Develop SAS programs for the creation of ADaM data sets following CDISC standards. Develop SAS programs for the creation of Tables, Listings and Figures. Validation of ADaM data sets, Tables, Listings and Figures. Create specifications for the structure of ADaM data sets for individual studies and integrated data. Create documentation for regulatory filings including reviewers guides and data definition documents Leads the development of standard SAS Macros and participates in the development of standard operating procedures. Provides oversight and mentoring of assigned Statistical Programmers and Statistical Analysts. **This is a US based remote position Qualifications MS in Statistics, Computer Science or a related field with 6+ years of relevant experience OR BS in Statistics, Computer Science or a related field with 8+ years of relevant experience. In-depth understanding of SAS programming concepts and techniques related to drug development. Fundamental understanding of CDISC Standards. Fundamental understanding of the drug development process, including experience with regulatory filings. Ability to communicate clearly both oral and written. Ability to accurately estimate effort required for study related programming activities. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit ************************************************************************* US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: *************************************************************

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. **Responsibilities and Accountabilities:** Strategic Statistical Leadership + Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. + Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). + Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership + Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: + Clinical trial biostatisticians + Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) + Medical Affairs statisticians + Statistical programmers + Biomarker/statistical genetics experts in oncology + RWE analysts/statistical epidemiologists + Safety/PV statisticians + Advanced analytics and modeling specialists + Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement + Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). + Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. + Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence + Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. + Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. + Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development + Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. + Share knowledge and best practices across study teams and therapeutic areas. + Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence + Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. + Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. + Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks. **Qualifications:** **Required** + PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline. + Minimum of 10 years of experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions. + Demonstrated experience leading statistical contributions at the compound level, including regulatory engagement and cross-functional integration. + Broad expertise across clinical trial design, exploratory oncology analytics, biomarker evaluation, RWE, and post-marketing study support. + Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming. + Strong understanding of the drug development lifecycle, regulatory requirements, and evidence generation for both approval and market access. + Ability to lead and influence cross-functional, global teams within a matrix environment. + Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences. + Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods. **Preferred:** + Prior experience in oncology or other complex therapeutic areas with evolving clinical and regulatory landscapes. + Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development. + Prior experience with solid tumor basket/umbrella trials, tumor-agnostic strategies, and adaptive development pathways. + Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions. + Contributions to ASCO, ESMO, or other oncology-related publications or working groups. + Scientific contributions through publications, presentations, or participation in industry/regulatory working groups. + Experience working with real-world data sources, including data integration, study design, and interpretation. + Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally. **Salary Range:** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest's headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that's us…that's Everest. To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Principal Biostatisticians for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA in accordance with our Work from Home policy. Key Accountabilities: Work with a leader of the Statistical Operations management team to manage clinical trial programs/projects from one or multiple clients. Provide day to day technical and operational leadership to project teams supporting these programs/projects. Provide statistical oversight on projects in the assigned drug development programs/projects, ensuring sound statistical methodologies in study design, sample size estimation, statistical analysis planning, statistical modeling, data handling, analysis, and reporting. Coach, mentor, develop, and provide technical review, advice and expertise to less experienced Biostatisticians as well as Statistical Programmers assigned to the program/projects. Provide statistical input in protocol design and development. Participate in the writing of trial protocols and research proposals. Serve as a primary biostatistician, working effectively with interdisciplinary teams to contribute strategically (through innovative ideas or applications) to drug development and commercialization at the study and drug compound/therapeutic areas levels. Review and provide input to clinical data management deliverables, including but are not limited to the following: eCRFs, eCRF Completion Instructions, data validation specifications, Data Review Plan (and the ongoing data review tables, listings, and figures in accordance with the Plan), and Data Management Plan. Write Statistical Analysis Plans, Statistical Reports, and statistical methodologies sections of Clinical Study Reports. Perform peer review of SAPs and other technical documents written by others. Perform hands on statistical analysis and modeling, and maintains expertise in state-of-the-art statistical methodology and regulatory requirements. Validate core statistical tables, listings, and figures programmed by statistical programmers and/or biostatisticians, ensuring that core results for each responsible trial are complete and accurate. Perform overall Quality Control review on statistical deliverables before they are released to the clients. Review and confirm ADaM dataset specifications. Perform quality control activities on ADaM datasets programmed by other statistical programmers and biostatisticians. Provide statistical consultation to medical and clinical trial personnel for the publication of trial results, and participate in the writing of abstracts, manuscripts, posters, and presentations. Ensure all study level as well as drug program level statistical and programming activities are conducted in compliance with relevant regulatory requirements and applicable standards/conventions. Interact with regulatory agencies and support sponsor in new drug application. This includes participating as a statistical liaison to the regulatory agency on behalf of the sponsor company and ensuring documentation, statistical results, and study datasets meet the regulatory agency's requirement/expectation (e.g., CDISC). Perform statistical and programming resource management, capacity analysis, benchmarking and metrics. Participate in the continuous improvement and maintenance of statistical and programming governing documents. Contribute to organization development and growth by participating in the interview and evaluation process for professional applicants. Qualifications and Experience: A Ph.D. degree in statistical science, mathematical analysis or related fields with at least 7 years of relevant experience or a Master's degree in these fields with at least 10 years of relevant experience, with demonstrated exceptional ability and performance. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at ***************** Estimated Salary Range: $140,000 - $175,000. We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-TK1 #INDHP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is hiring a Principal Biostatistician to work remotely. The Principal Biostatistician works independently on all level complexity clinical trial projects, often with major regulatory impact. The person will be recognized internally and externally as a statistical expert. Location: United States - Remote Key Accountabilities: Operational Execution Provide broad statistical support, including trial design, protocol and CRF development on specific studies Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documents Perform sample-size calculations, generate randomization lists and write statistical methodology sections for inclusion in study protocols Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans Provide a supporting role as a non-voting independent statistician providing data and analysis for DMC review Business Development Support of Business Development, by actively contributing to study design considerations in internal and client meetings, providing and discussing sample size scenarios, support of budget and proposal development, attending and preparing bid defense meetings General Activities Understand regulatory requirements related to the specific therapeutic areas and the implications for statistical processing and analysis Understand, apply and provide training in extremely advanced and sometimes novel statistical methods Contribute to the development and delivery of internal and external statistical training seminars and courses Review position papers based on current good statistical practice Interact with clients and regulatory authorities Review publications and clinical study reports Travel to, attend, and actively contribute to all kind of client meetings as appropriate (e.g. discussing analysis concepts, presenting and discussing study results) Additional responsibilities as defined by supervisor/manager. Skills: Good analytical skills Good project management skills Professional attitude Attention to detail Thorough understanding of statistical issues in clinical trials Ability to clearly describe advanced statistical techniques and interpret results Familiarity with regulatory/research guidelines on drug development, GCP, and statistical principles (especially ICH guidelines) Prior experience with SAS programming required Ability to work independently Good mentoring/leadership skills Good business awareness/ business development Knowledge and Experience: PhD or MS in Statistics or related discipline with substantial experience The knowledge of pharmacokinetic data is an advantage Competent in written and oral English in addition to local language Education: PhD in Statistics or related discipline, MS in Statistics or related discipline EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Our client is a leading CRO with a fantastic reputation for delivering quality results. They are currently looking for Biostatisticians at all levels, and these positions can be remote. All the Biostatisticians here are hands-on; some have managerial responsibilities, and some are individual contributor roles. They do ask that Biostatisticians have strong programming skills, though there is a Programming team there as well for support. Also, a good grasp of CDISC, ADaM, and SDTM standards is important here. This CRO has a mix of both FSP and standard outsourcing models ranging from small to large pharma and biotech companies so there is much opportunity to contribute in various, diverse ways across phases and therapeutic areas. This is a fantastic opportunity to deepen and broaden your statistical experience in a well-established and stable company.