Backed by GV.
About the role
The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase oncology clinical trials (Phase I/II). This is a high-impact, trial-focused role responsible for authoring statistical analysis plans, executing complex statistical models, and directly analyzing data for novel cancer therapies.
What they're looking for
- Ph.D. in Biostatistics or Statistics with 6+ years of biotech/pharma experience, OR
- M.S. in Biostatistics or Statistics with 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 (specifically for trial simulations, complex oncology datasets, and visualization packages like Shiny)
- Expert knowledge of early oncology endpoints (e.g., DLT, PFS, ORR, RECIST 1.1, Lugano criteria)
More about this role
The Director of Biostatistics will lead the statistical strategy, design, and trial-level execution for early-phase oncology clinical trials (Phase I/II). This is a high-impact, trial-focused role responsible for authoring statistical analysis plans, executing complex statistical models, and directly analyzing data for novel cancer therapies. The Director ensures that early-development trials—from First-in-Human (FIH) dose escalation to Proof-of-Concept (PoC)—are designed and analyzed with the highest level of scientific rigor.
Trial Design & Execution
- Trial Architecture: Lead the statistical design and execution of individual oncology protocols, including sample size calculations, randomization schemes, and adaptive design simulations.
- Statistical Modeling: Implement and execute trial-level dose-finding methodologies, such as Bayesian Optimal Interval (BOIN), and cohort expansion models.
- Analysis & Programming: Program, validate, and perform statistical analyses for trial data cuts, Safety Review Committees, and Dose Escalation Meetings.
- SAPs & Output: Author trial-specific Statistical Analysis Plans, design shell tables, listings, and figures (TLFs), and write...
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