Executive Director Biostatistics

Role: Executive Director of Biostatistics leading clinical data activities within Clinical Development for a radiopharmaceutical company. Responsibilities: oversee biostatistics functions, develop statistical strategies for multi-therapeutic clinical trials (oncology, neurology, cardiology), manage CROs/vendors, contribute to protocol design, statistical analysis plans, and regulatory submissions (NDAs, INDs). Lead and mentor the biostatistics team, ensure regulatory-compliant data delivery, and stay current with statistical methodologies. Skills/Qualifications: PhD in Biostatistics or related field; 20+ years in pharma/CRO with at least 10 in management; extensive experience in clinical study design, statistical programming (SAS), and regulatory documentation; prior lead biostatistician experience preferred. Biopharma specifics: focus on radiopharmaceuticals, diagnostics (PET), and multiple phases of development, with experience in regulatory interactions and submission preparations. Collaboration: work closely with clinical, regulatory, and cross-functional teams. Work setup: based in Bedford, MA with a hybrid onsite requirement (2-3 days/week). High-value: senior leadership role, broad therapeutic scope, regulatory submission expertise, and extensive industry experience.