About the role
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 statistical sections of Clinical Study Reports (CSRs). Data Visualization & Insights Visual Reporting: Design and build dynamic data visualizations, dashboards, and interactive graphics (e.g., using R/Shiny) to track real-time dose escalation, safety signals, and biomarker trends. Translate complex statistical outputs and trial models into intuitive, high-impact visual decks for executive leadership, investors, and scientific advisory boards. Regulatory & Vendor Deliverables Data Standards: Oversee trial-level data compliance, mapping data structures strictly to CDISC standards (SDTM, ADaM) for early-phase tracking. CRO Management: Provide direct technical oversight to CRO programmers and biostatisticians, verifying all trial-level deliverables for quality and accuracy. Regulatory Submissions: Prepare data packages and statistical rationales for Investigational New Drug (IND) submissions and expedited regulatory filings. Cross-Functional Collaboration Study Teams: Serve as the core biostatistician on clinical trial working groups, collaborating daily with Clinical Leads, Data Managers, and Biomarker scientists. Data Integration: Blend pharmacokinetic (PK/PD) and translational biomarker data into trial-level exploratory analyses to identify early safety or efficacy signals.