Director, Biostatistics

Role: Lead Study Statistician responsible for designing, executing, and analyzing clinical trials in Sarepta's biopharma portfolio focused on genetic and muscular disorders, with potential progression to Program Statistical Lead for strategic oversight. Responsibilities: develop and implement statistical strategies across trials, including adaptive designs; provide statistical leadership for regulatory submissions and interactions with agencies like FDA and EMA; oversee CRO/vendor activities; contribute to biostatistics standards and mentor team members. Requirements: Ph.D. (preferred) or Master's in Biostatistics/Statistics with 9+ (Ph.D.) or 10+ (Master's) years of industry experience, including direct clinical trial leadership; strong expertise in trial design, adaptive methodologies, and statistical programming in R/SAS; comprehensive understanding of GCP, regulatory guidance, and biopharma development phases, especially Phase 2 and 3. HighValue: genetic medicine, Duchenne muscular dystrophy, biologics, clinical trial design, adaptive methodologies, regulatory submissions, sponsor-side experience, hands-on statistical programming, cross-functional collaboration, hybrid work in the U.S.