Director, Biostatistics

Role: Lead Study Statistician in biopharma, responsible for statistical strategy and execution across clinical studies in gene therapy and rare disease areas, including Duchenne muscular dystrophy. Objectives include designing, analyzing, and reporting clinical trials, progressing to Program Statistical Lead to guide cross-study methodologies and regulatory interactions. Responsibilities encompass end-to-end statistical leadership, trial design (including adaptive methodologies), overseeing external vendors and CROs, and contributing to regulatory submissions and discussions with agencies like FDA and EMA. The role demands hands-on expertise in R/SAS, developing analysis datasets, SAPs, and CSR reviews, while mentoring biostatistics team members. Qualifications: Ph.D. (preferred) or Master’s in Statistics/Biostatistics with 9+ or 10+ years of relevant experience respectively, with substantial sponsor-side clinical trial leadership—preferably in Phase 2/3 pivotal studies—within biotech/pharma. Expertise in adaptive trial designs, multiplicity, estimands, missing data, and GxP regulatory standards is essential. Biopharma specifics: focus on gene therapies, rare diseases, and regulatory interactions; GCP compliance; cross-functional collaboration with Clinical Development, Data Management, Medical, Regulatory, and external vendors. Work setup: hybrid, based in the U.S., with onsite requirements and occasional in-person events. The position offers a competitive salary range of $206K-$258K, aligned with experience and market factors.