Director, Biostatistics

Role: Senior biostatistics leader responsible for strategic statistical expertise within Ipsen's neuroscience development portfolio. Responsibilities: act as program-level lead biostatistician, providing technical leadership in trial design, analysis, and regulatory interactions; author and review key study and regulatory documents; oversee CROs and vendor collaborations; promote innovative methodologies such as adaptive designs and Bayesian approaches; support regulatory submissions and internal analyses; mentor team members; and contribute to process improvements and strategic initiatives. Requirements: MS in statistics or biostatistics with 10+ years industry experience (or 12+ with MS), extensive knowledge of clinical trial designs, statistical methodologies, and programming (SAS, R, CDISC standards); excellent communication skills; proven leadership in cross-functional teams; strong project management. Preferred: neuroscience development experience and regulatory submission expertise. HighValue: neuroscience therapeutic area, clinical development stage encompassing complex study designs, adaptive trial methodologies, regulatory engagement (FDA, EMA, PMDA), and working with global, cross-functional teams. WorkSetup: not specified; likely hybrid or remote based on industry norms.