Senior Director, Biostatistics

About the role

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 This individual will work with cross-functional teams to advance transformative precision genetic medicines in DMD or 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 be able to lead a Biometrics team comprising biostatisticians and statistical programmers and excel as a hands-on innovative biostatistician. The ideal candidate will be a strategic thinker, a good communicator, high-energy, self-motivated, and forward thinking. Experience working in rare disease or gene therapy is desirable, but not required. The Opportunity to Make a Difference Provide statistical strategies and expertise for clinical development, regulatory submission, and patient access data generation for the assigned clinical development program or functional areas Be accountable for all statistical aspects of assigned clinical development programs or functional area, including clinical development plans, protocols and regulatory submissions Oversee collaboration with internal and external (e.g., CRO) team members to coordinate 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 members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives Lead/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 Be accountable for statistical activities in support of IND/NDA/MAA or other regulatory submissions Address statistical questions/comments from FDA, EMA, and other regulatory agencies, and review and address comments by IRB/ECs Author or oversee the development of statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and oversee the development of shells for tables, figures, and listings Represent Sarepta regarding statistical issues with external parties including regulatory agencies and corporate partners Contribute to clinical protocol development, including authoring of the Statistics section and reviewing of other sections by applying statistical principles Review case report form (CRF) designs to ensure data collection meets the requirements of statistical analyses Design and specify randomization schedules; review and approve test randomization lists Provide statistical input to data monitoring committee (DMC) charters, independent review charters, and other study-level documents Perform ad hoc and exploratory statistical analyses as needed Contribute to clinical study reports, including authoring of statistical methods and interpretation of the study results Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations Contribute or lead standardization and process improvement efforts for Biometrics and contribute to cross-functional process improvement efforts Participate in development and implementation of functional or cross-functional SOPs for process simplification, standardization or improvement Develop and lead a team of high performing biostatisticians to meet corporate, R&D, and program goals 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 defen