Executive Director, Biostatistics

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 Importance of the Role

This individual will provide strategic statistical leadership across a group of clinical development programs in DMD or the siRNA platform. The role requires a leader who can operate 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 must lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. They will be recognized as an influential leader across the organization and externally, shaping clinical development strategy — not solely executing within it. The ideal candidate will be a strategic thinker, a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease, gene therapy or siRNA modalities is desirable, but not required.

The Opportunity to Make a Difference

The Opportunity to Make a Difference

• Be accountable for all statistical and data aspects of an assigned group of clinical development programs, including clinical development plans, protocols, and regulatory submissions, or be responsible for 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) that meet their objectives while complying with regulations and quality standards
• Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
• Oversee optimization of statistical methods for the design, conduct, analysis, and reporting of clinical studies, and to address identified or potential statistical issues arising in studies or programs
• Oversee planning and execution of statistical activities in support of IND/NDA/MAA or other regulatory submissions while maintaining an active role in cross-functional strategies and preparation of regulatory submissions
• Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs
• Represent Sarepta regarding statistical issues with external parties including regulatory agencies and corporate partners
• Oversee vendors with respect to key performance indicators, metrics, and key deliverables and timelines
• Oversee project budget/resource planning, re-forecasting, and milestones, along with other functions
• Lead or participate in development and implementation of 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 that pairs pre-specified confirmatory analyses with fit-for-purpose exploratory analytics, enabling the team to interrogate data rapidly while maintaining regulatory defensibility
• Partner closely with Clinical Development, Medical Affairs, and Regulatory to translate emerging scientific questions into actionable exploratory analysis plans, ensuring Biometrics is embedded in decision-making, not just repo