Executive Director, Biostatistics

Why Sarepta?

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

Benefits

Sarepta is committed to supporting employees in all aspects of their lives through a range of benefits and work-life resources, including:

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

For a full list of comprehensive benefits, visit Sarepta’s careers page.

About the Role

This individual will provide strategic statistical leadership across a group of clinical development programs in Duchenne muscular dystrophy (DMD) or the siRNA platform. The role requires operating across both confirmatory and exploratory analytics—driving rigorous regulatory-grade deliverables while fostering a culture of rapid, hands-on data exploration in close partnership with clinical development. The ideal candidate will lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on, innovative biostatistician. They will shape clinical development strategy as an influential leader both internally and externally.

Responsibilities

• Be accountable for all statistical and data aspects of assigned clinical development programs, including clinical development plans, protocols, and regulatory submissions, or oversee assigned areas of Biostatistics functional-level oversight.
• Oversee the planning and execution of Biometrics or Biostatistics deliverables from internal and external teams (e.g., CRO) to meet objectives while complying with regulations and quality standards.
• Interact with senior members in other functional areas for strategic planning to optimize clinical development in alignment with corporate objectives.
• Oversee optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, addressing identified or potential statistical issues.
• Oversee statistical activities supporting IND/NDA/MAA or other regulatory submissions, maintaining an active role in cross-functional strategies and preparation.
• Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review comments by IRB/ECs.
• Represent Sarepta on statistical issues with external parties, including regulatory agencies and corporate partners.
• Oversee vendors with respect to key performance indicators, metrics, and deliverables.
• Lead project budget/resource planning, re-forecasting, and milestones alongside other functions.
• Lead or participate in developing and implementing functional or cross-functional SOPs for process simplification, standardization, or improvement.
• Represent Biometrics or Biostatistics in cross-functional teams or committees.
• Champion a modern analytics operating model pairing pre-specified confirmatory analyses with fit-for-purpose exploratory analytics to enable rapid data interrogation while maintaining regulatory defensibility.
• Partner closely with Clinical Development, Medical Affairs, and Regulatory to translate emerging scientific questions into actionable exploratory analysis plans, embedding Biometrics in decision-making.
• Lead rapid-response analytical efforts (e.g., post-readout deep dives, ad-hoc regulatory queries) with clear scientific triage, prioritization, and interpretation under compressed timelines.
• Define governance guardrails for exploratory work, including risk-based validation, documentation standards, and clear separation from submission-quality deliverables.
• Foster a culture where biostatisticians are hands-on analysts and scientific architects, engaging with data exploration using modern tools (R, Python, interactive visualization) alongside traditional SAS workflows.
• Coach, mentor, and manage the performance of direct reports, and serve as a mentor to junior managers and team members.

Requirements

• Ph.D. in statistics or a related discipline with 15+ years, or a Master’s Degree with 18+ years of experience in the pharmaceutical or biotech industry.
• Proven track record in a senior leadership role managing a team.
• Demonstrated statistical leadership in clinical development and experience contributing to clinical development plans.
• Expertise in the design, analysis, and reporting of clinical trials.
• Experience as Biostatistics lead for NDAs, MAAs, or other regulatory submissions.
• Extensive experience interacting with regulatory agencies.
• In-depth knowledge of statistical methods for clinical trials, including both frequentist and Bayesian approaches.
• Ability to address unconventional statistical questions arising in clinical research and drug development.
• In-depth knowledge of FDA, EMA, and ICH regulations and guidelines.
• Knowledge of immunology and/or gene therapy is desirable but not required.
• Experience with external control arms, real-world data, or causal inference methods is a plus.
• Proficient in statistical programming in SAS and R; Python and other languages are a plus.
• Proficient in statistical design software (e.g., EAST).
• Adept at outsourcing and managing biostatistical services provided by CROs and/or contractors.
• Ability to communicate statistical information to non-scientists and willingness to educate internal teams.
• Extensive experience managing a Biostatistics or Biometrics team and overall resource planning.
• Demonstrated ability to drive Biostatistics or Biometrics functional goals in alignment with corporate goals.
• Comfort operating in a dual-track model: formal SAP-driven analyses alongside agile, hypothesis-driven exploration.
• Enthusiasm for harnessing modern AI tools and workflows and championing their responsible adoption across the Biometrics team.
• Track record of partnering with clinical development teams as a strategic thought partner, not just a service function.

Pay

The targeted salary range for this position is $256,000 - $320,000 per year. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including education, training, experience, external market conditions, criticality of role, and internal equity.

Schedule

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.