Head of Biostatistics
Head of Biostatistics (ED/VP) - Oncology
Location: Boston (Onsite)
Overview
A rapidly growing oncology‑focused biotechnology company in Boston is seeking their first in‑house Head of Biostatistics (Executive Director or Vice President level). This foundational hire will build, lead, and execute the company's Biostatistics function while contributing hands‑on to clinical trial design, data strategy, and regulatory interactions. The ideal candidate brings deep oncology expertise, thrives in small biotech environments, and communicates statistical concepts with clarity and influence.
Key Responsibilities
- Serve as the organization's senior statistical leader, overseeing strategy across all oncology clinical programs (Phases I-III).
- Lead the design, analysis, and interpretation of clinical trials, including adaptive and Bayesian methodologies.
- Partner cross‑functionally with Clinical Development, Regulatory, Clinical Operations, and external partners to ensure high‑quality program execution.
- Develop statistical components of regulatory submissions and drive preparation for NDA/BLA filings.
- Represent the company in FDA and global health authority interactions, providing statistical justification and responding to regulatory queries.
Ideal Candidate Profile
- Local to the Boston area and able to report onsite 5 days a week.
- Extensive oncology experience with contributions across Phase I-III programs and multiple NDA/BLA submissions.
- Prior experience in small biotech, ideally serving as the first biostatistics hire or building out a function from early stages. (Open to big pharma experience as well)
- Significant experience in direct FDA and global regulatory interactions.
- Hands‑on mindset with the ability to balance strategic leadership and day‑to‑day execution.
Qualifications
- Ph.D. in Biostatistics, Statistics, or related quantitative discipline.
- 10+ years of relevant industry experience, primarily in oncology drug development.
- Proven leadership in statistical strategy for clinical programs and regulatory submissions.
- Proficiency in modern trial design, simulation‑based methods, and advanced statistical approaches.
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