Director, Biostatistics

Role: Lead biostatistics strategies for Syndax’s clinical development programs, providing expertise in study design, analysis, and regulatory submissions. Responsibilities: optimize trial designs for early and late-phase studies, support study conduct in collaboration with clinical teams, oversee external CRO deliverables, serve as statistical lead for IND/NDA/MAA interactions, review clinical documents, author analysis plans, and ensure compliance with regulatory standards. Collaborate with Medical Affairs and other functions for evidence generation and publications, stay current with advancements in statistical methodology, and lead biostatistics initiatives. Requirements: Ph.D. or M.S. in Biostatistics or related field, minimum 5 years of relevant industry experience, strong expertise in clinical trial design, statistical analysis, and regulatory requirements; proficiency in SAS and other statistical software. Preferred: strategic thinker with excellent communication, leadership, and cross-functional collaboration skills. HighValue: oncology focus, clinical development (early and late-phase), involvement in IND/ NDA/ MAA processes, GxP compliance, and cross-functional teamwork. Location: Remote, based in New York, NY.