Director, Biostatistics

Director of Biostatistics

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.

 

Responsibilities

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 stat