Director, Biostatistics

Role: Senior Biostatistician specializing in clinical trial data analysis within Sarepta's rare disease (Duchenne muscular dystrophy and gene therapy) programs. Objectives include leading statistical design, analysis, and reporting for clinical trials, supporting regulatory submissions (IND/NDA/MAA), and providing insights for program decisions. Responsibilities encompass collaborating with CROs, designing statistical models, authoring SAPs, reviewing CRFs, developing randomization schedules, supporting DMCs, and conducting exploratory data analyses using modern tools like R, Python, and SAS. The role also involves contributing to clinical protocol development, study reports, regulatory interactions, and cross-functional process improvements, while mentoring junior team members. Qualifications: Ph.D. (preferred) or Master’s in statistics or related field with 9+ or 10+ years of industry experience, respectively. Expertise in clinical trial design, analysis, regulatory submissions, and statistical software (SAS, R, Python, EAST). Knowledge of FDA, EMA, ICH guidelines, and data standards (SDTM, ADaM) is required. Experience in rare diseases, gene therapy, or neuromuscular disorders is desirable. The candidate must demonstrate strong communication skills, the ability to oversee CROs, and capacity for hands-on data exploration. Location: Hybrid working arrangement with US-based facilities and occasional in-person events. The position offers a competitive salary range ($206K–$257.5K) and benefits, with an emphasis on innovative analytical practices and scientific collaboration.