Executive Director, Biostatistics

About 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 role provides strategic statistical leadership across a group of clinical development programs in Duchenne muscular dystrophy (DMD) or the siRNA platform. The position requires leadership in both confirmatory and exploratory analytics, driving regulatory-grade deliverables while fostering rapid, hands-on data exploration in partnership with clinical development. The ideal candidate will lead a Biometrics team of biostatisticians and statistical programmers and serve as an influential leader shaping clinical development strategy.

Responsibilities

• Be accountable for all statistical and data aspects of assigned clinical development programs, including clinical development plans, protocols, and regulatory submissions.
• 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 the optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, addressing identified or potential statistical issues.
• Plan and execute statistical activities in support of 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.
• Manage project budget/resource planning, re-forecasting, and milestones.
• Lead or participate in the development and implementation of functional or cross-functional SOPs for process simplification and standardization.
• Represent Biometrics or Biostatistics in cross-functional teams or committees.
• Champion a modern analytics operating model that pairs pre-specified confirmatory analyses with fit-for-purpose exploratory analytics.
• Partner closely with Clinical Development, Medical Affairs, and Regulatory to translate emerging scientific questions into actionable exploratory analysis plans.
• Lead rapid-response analytical efforts (e.g., post-readout deep dives, ad-hoc regulatory queries) with clear scientific triage and prioritization under compressed timelines.
• Define governance guardrails for exploratory work, including risk-based validation and documentation standards.
• Foster a culture where biostatisticians engage hands-on with data exploration using modern tools (R, Python, interactive visualization) alongside traditional SAS workflows.
• Coach, mentor, and manage the performance of direct reports.
• 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 for clinical development and ability to contribute 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 frequentist and Bayesian approaches.
• Ability to address unconventional statistical questions in clinical research and drug development.
• In-depth knowledge of FDA, EMA, and ICH regulations and guidelines.
• Experience with external control arms, real-world data, or causal inference methods is a plus.
• Proficiency in statistical programming in SAS and R; Python and other languages are a plus.
• Proficiency 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 educate internal teams.
• 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.
• Track record of partnering with clinical development teams as a strategic thought partner.

Knowledge of immunology and/or gene therapy is desirable but not required. Candidates must be authorized to work in the U.S.

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.