Director, Biostatistics

Lead Study Statistician

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

The person in this position will serve as a Lead Study Statistician, taking ownership of the statistical strategy and execution for assigned clinical studies from protocol development through database lock, data analysis, interpretation, and reporting. As the clinical development portfolio advances, the individual will progressively assume responsibility as the Program Statistical Lead, providing strategic statistical leadership across studies and development stages and partnering with Clinical Development and senior leadership on key program decisions.

The successful candidate will have 9+ years of meaningful, hands-on clinical trial experience within a pharmaceutical or biotechnology company. Sponsor-side experience is strongly preferred. The candidate should have demonstrated experience with clinical trial design, including adaptive trial designs, statistical analysis, regulatory submissions, and direct interaction with cross-functional clinical development teams.

This role requires an individual who combines strong statistical methodology with practical clinical development judgment and who is comfortable being both hands-on technically and influential strategically. The successful candidate should be capable of independently developing statistical analyses in R and/or SAS, while also providing statistical leadership to internal and external programming resources.

The Opportunity to Make a Difference

• Provide end-to-end statistical leadership for assigned clinical trials, from study design and protocol development through analysis, interpretation, and reporting. Partner closely with cross-functional teams to ensure scientifically rigorous study designs, high-quality analyses, and successful execution of statistical deliverables.
• Lead the statistical design of clinical trials, including endpoint strategy, sample size, randomization, interim analyses, and other key methodological considerations. Provide hands-on expertise in adaptive trial design, including evaluation, implementation, and interpretation of innovative approaches to optimize clinical development efficiency and decision-making.
• As the clinical development portfolio matures, progressively assume the role of Program Statistical Lead. Provide strategic statistical leadership across the clinical development program, ensuring alignment of study designs, methodologies, analyses, and evidence across development stages. Partner with Clinical Development and senior leadership to guide key program decisions, pivotal study strategy, integrated analyses, and regulatory strategy.
• Provide statistical leadership and hands-on support for regulatory submissions, including pivotal analyses, submission documents, analysis datasets, and responses to regulatory inquiries. Contribute to and, as appropriate, lead statistical discussions with FDA, EMA, and other health authorities, ensuring robust and defensible statistical strategies throughout regulatory review.

• Partner closely with Clinical Development, Clinical Operations, Data Management, Medical, Regulatory, Statistical Programming, and other functions to drive scientifically rigorous and operationally feasible clinical development strategies. Serve as a trusted statistical advisor, clearly communicating complex statistical concepts and influencing cross-functional decisions through sound judgment and collaboration.
• Provide statistical oversight and direction to CROs and external vendors while retaining overall accountability for statistical strategy, methodology, interpretation, and scientific quality. Critically review deliverables, ensure adherence to study requirements and timelines, and proactively resolve statistical issues to support high-quality clinical trial execution.
• Maintain hands-on expertise in R and/or SAS to independently develop, review, troubleshoot, and validate statistical analyses, outputs, and associated documentation. Provide technical oversight of statistical programming and analysis datasets while ensuring robust implementation of statistical methodologies and data standards.
• Contribute to building and advancing the Biostatistics function through development of statistical standards, best practices, processes, and capabilities. Mentor and develop statisticians and statistical programmers while contributing to hiring, resource planning, and team growth as the organization expands.

More about You

• Ph.D. (strongly preferred) in Statistics / Biostatistics with 9+ years, or a Master's degree in Statistics / Biostatistics with 10+ years of progressive biostatistics experience in the pharmaceutical or biotechnology industry, including demonstrated technical expertise and hands-on experience applying advanced statistical methodologies. Candidates with a Master's degree must demonstrate a strong track record of independently applying advanced statistical methods to complex biostatistical problems.
• Candidates whose experience is primarily as a CRO/vendor statistician providing statistical services to sponsors, without meaningful sponsor-side ownership of clinical development studies, will not meet the core experience requirement.
• At least 8 years of substantial, direct clinical trial experience, preferably spanning multiple phases of clinical development.
• Demonstrated experience leading the statistical design, execution, analysis, reporting, and regulatory support of clinical trials as a study statistician, lead statistician, or equivalent statistical lead within a sponsor organization, preferably including Phase 2 and Phase 3/pivotal studies.
• Strong expertise in clinical trial methodology and statistical principles, including adaptive designs, sample size determination, randomization, interim analyses, multiplicity, estimands, missing data, sensitivity analyses, and subgroup analyses.
• Strong hands-on statistical programming skills in R and/or SAS, with experience developing and reviewing SAPs, TFL specifications, integrated analyses, CSRs, and regulatory submission materials.
• Strong understanding of GCP and applicable statistical and regulatory guidance.
• Excellent written and verbal communication skills.
• Demonstrated ability to work effectively in a cross-functional, collaborative environment.
• Ability to operate independently, prioritize competing demands, and make sound statistical decisions with limited supervision.
• Enthusiasm for learning and harnessing modern AI tools and workflows to enhance analytical productivity and scientific insight.

What Now?

We're always looking for solution-oriented, critical thinkers.

So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.

This position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time. The targeted salary range for this position is $206,000 - $257,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.