Director, Biostatistics

Role: Lead and execute biostatistics strategy for Phase 1–3 clinical trials, focusing on oncology and inflammation indications, ensuring regulatory compliance and high-quality deliverables. Responsibilities: develop trial designs, statistical analysis plans, and analysis strategies; author and review key regulatory documents; oversee CRO activities, ensuring data integrity, timely delivery, and adherence to industry standards; collaborate with clinical teams for data review, regulatory submissions, and cross-functional alignment; mentor statistical programming teams for compliant dataset production and analysis outputs. Requirements: PhD in Biostatistics, Statistics, or related field; 15+ years supporting clinical drug development; extensive experience with CRO collaboration, regulatory standards (FDA, ICH), and clinical trial statistics; proficiency in SAS and other statistical tools. Preferred: deep expertise in oncology and inflammatory disease trials, with a track record in regulatory submissions and complex studies. High-value specifics: leadership in late-stage (Phases 1–3) oncology/inflammation trials, regulatory interactions, statistical programming oversight, and industry-standard methodologies. Location: Boston, MA; role involves active collaboration with external partners and internal teams, with a focus on delivering scientifically robust and regulatory-compliant results.