Director, Biostatistics
$226,425–$257,000 year
On-siteWatertown, Massachusetts, United States
Job Summary
Lead statistical strategy, design, and trial-level execution for early-phase oncology clinical trials (Phase I/II), authoring analysis plans and performing complex modeling including Bayesian Optimal Interval dose-finding. Program and validate statistical analyses for trial data cuts, Safety Review Committees, and Dose Escalation Meetings while overseeing CRO programmers and biostatisticians. Design dynamic data visualizations and dashboards to track real-time dose escalation, safety signals, and biomarker trends, translating complex outputs into intuitive decks for executive leadership and investors. Prepare data packages and statistical rationales for Investigational New Drug submissions and ensure strict CDISC compliance. Serve as the core biostatistician on clinical trial working groups, collaborating daily with Clinical Leads, Data Managers, and Biomarker scientists to blend pharmacokinetic and translational data.
Required Qualifications
- Ph.D. in Biostatistics or Statistics
- 6+ years of biotech/pharma experience
- M.S. in Biostatistics or Statistics
- 8+ years of biotech/pharma experience
- Minimum of 3 years of hands-on experience designing, modeling, and analyzing early-phase oncology trials (Phase I/II)
- Proven track record of taking individual oncology trials from protocol design through final CSR
- Advanced, hands-on programming expertise in R and SAS
- Expert knowledge of early oncology endpoints (e.g., DLT, PFS, ORR, RECIST 1.1, Lugano criteria)
Desired Qualifications
- Comfort working in a fast-paced environment with a high volume of early-stage data iterations
- Outstanding written and verbal communication skills
- Proven ability to influence matrixed teams
- Ability to explain statistical concepts simply
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