Director, Biostatistics , Biometric Sciences

Role: Lead biostatistics function within clinical development for antibody-based therapies targeting autoimmune and rare diseases. Responsibilities: serve as biostatistics leader, develop study strategies, oversee statistical analysis plans, collaborate with internal teams and external vendors, ensure regulatory compliance, and contribute to submission documents. Requirements: PhD with 8+ years or MS with 12+ years in biotech/pharma/clinical research, expertise in statistical methods, proficiency in SAS/R/Python, knowledge of FDA/EU/ICH guidelines, and experience managing CROs and supporting regulatory submissions. HighValue: biologics, monoclonal antibodies, autoimmune/rare disease indications, clinical stage development, regulatory interactions, statistical programming, and data analysis. WorkSetup: hybrid in Waltham, MA or fully remote with ~10% travel.