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Scorpion Therapeutics is seeking an Executive Director of Biostatistics to lead clinical data activities within Clinical Development for a radiopharmaceutical company. The role oversees statistical strategy across multi-therapeutic programs and ensures regulatory-compliant data delivery.
The candidate will lead and mentor the biostatistics team, collaborate with clinical and regulatory colleagues, manage CROs/vendors, and drive protocol design, SAPs, and regulatory submissions (NDAs/INDs) across
Executive Director of Biostatistics leading clinical data activities within Clinical Development for a radiopharmaceutical company.
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.
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.
focus on radiopharmaceuticals, diagnostics (PET), and multiple phases of development, with experience in regulatory interactions and submission preparations.
work closely with clinical, regulatory, and cross-functional teams.
based in Bedford, MA with a hybrid onsite requirement (2-3 days/week).
senior leadership role, broad therapeutic scope, regulatory submission expertise, and extensive industry experience.