Director, Biostatistics

sarepta; Cambridge (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Sarepta seeks a Lead Study Statistician to take ownership of statistical strategy and execution for assigned clinical studies, from protocol development through database lock, data analysis, interpretation, and reporting.

As the program matures, you will advance to Program Statistical Lead, providing strategic statistical leadership across development stages and partnering with Clinical Development and senior leadership on key program decisions.

Qualifications

• 9+ years of hands-on clinical trial experience in pharma/biotech.
• Experience with adaptive trial designs, regulatory submissions, and cross-functional collaboration.
• Ability to develop statistical analyses in R and/or SAS and provide leadership to programming resources.
• Sponsor-side experience preferred.

Responsibilities

• Provide end-to-end statistical leadership for assigned clinical trials.
• Design endpoints, sample size, randomization, interim analyses.
• Lead adaptive trial design initiatives for development efficiency.
• Collaborate with cross-functional teams and senior leadership.
• Oversee regulatory submissions and interactions with agencies.
• Maintain hands-on expertise in R and SAS.

Skills

Statistical leadership

Hands-on clinical trials

Adaptive trial design

R and SAS programming

Tools

R

SAS

Job description

Why Sarepta? Why Now?

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.

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us

The Importance of the Role

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