Posted 2 days ago
Vice President, Biometrics
AI Summary
The Vice President, Biometrics provides executive leadership for biostatistics strategy and execution across oncology clinical development programs, leading trial design, team building, and regulatory interactions from IND to BLA.
About this role
We are seeking an experienced and strategic Vice President, Biostatistics. This role may be based in a hybrid capacity from our Waltham, MA office or remotely from the East Coast. Reporting to the Chief Medical Officer, you will provide executive leadership across biostatistics activities, with an initial focus on CR-001, a PD-1/VEGF bispecific antibody, our lead asset. You will build the team, set the strategy, and be accountable for the statistical framework that supports our pipeline from IND through registration and BLA submission, with a strong emphasis on oncology drug development within a biotech environment. You will serve as the statistical voice of the organization — shaping the quantitative foundation of every program in our pipeline. This role is based in Waltham, MA and you must have experience in the oncology space.
Responsibilities
- Define and execute the biostatistics strategy, setting clear goals aligned with oncology clinical development objectives.
- Provide statistical leadership in the design and execution of clinical trials across all stages of development, including registrational strategies.
- Build a high-performing team and establish processes, SOPs, and governance frameworks to ensure efficiency, standardization, and compliance across the portfolio.
- Drive innovation in statistical methods and analytics to improve decision-making and execution speed.
- Lead the design and review of clinical protocols, including statistical considerations, sample size calculations, interim analyses, randomization approaches, and study design recommendations.
- Ensure biostatistics activities support regulatory readiness, including adherence to CDISC and other regulatory standards.
- Serve as a core representative in cross-functional meetings, aligning biostatistics strategy with clinical development, regulatory affairs, and quality assurance.
- Lead interactions with health authorities (e.g., FDA, EMA, PMDA) to address statistical questions during regulatory reviews.
- Oversee CRO and vendor strategy, including vendor selection, relationship management, performance oversight, and cost optimization.
- Establish and maintain strong partnerships with external vendors and service providers to support clinical development objectives and operational excellence.
- Build, recruit, and retain a high-performing internal Biostatistics team; manage headcount planning in alignment with pipeline milestones.
