Senior Manager/Associate Director, Biostatistics

Role: Senior Manager / Associate Director of Biostatistics focused on clinical trial data analysis and interpretation for Rapport's bipolar mania program, including indications in epilepsy and bipolar disorder. Responsibilities: lead statistical aspects of multiple studies, oversee protocol development, statistical analysis plan creation, and ensure regulatory compliance (FDA, EMA, ICH); support data programming (SDTM, ADaM) and collaborate with cross-functional teams including clinical, regulatory, and medical affairs; manage CROs and external vendors. Requirements: PhD with 3+ (Senior Manager) or 6+ years (Associate Director) in biostatistics; expertise in CNS drug development, survival analysis, adaptive design, and programming with SAS or R; deep knowledge of clinical trial design, regulatory standards, and CDISC (SDTM, ADaM). Preferred: experience in neuromedicine, precision medicine, and early to late-stage clinical trials. High-Value: CNS indications, bipolar disorder, epilepsy, clinical trial design, regulatory submissions, statistical programming, cross-functional collaboration, hybrid work setup, and leadership in biostatistics. Location: hybrid in San Diego or Boston; travel not specified.