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.