Director Biostatistics

Responsibilities

• Lead the statistical design and execution of individual oncology protocols, including sample size calculations, randomization schemes, and adaptive design simulations.
• Implement and execute trial-level dose-finding methodologies, such as Bayesian Optimal Interval (BOIN), and cohort expansion models.
• Program, validate, and perform statistical analyses for trial data cuts, Safety Review Committees, and Dose Escalation Meetings.
• Author trial-specific Statistical Analysis Plans, design shell tables, listings, and figures (TLFs), and write statistical sections of Clinical Study Reports (CSRs).
• 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.
• Provide direct technical oversight to CRO programmers and biostatisticians, verifying all trial-level deliverables for quality and accuracy.
• Prepare data packages and statistical rationales for Investigational New Drug (IND) submissions and expedited regulatory filings.
• Serve as the core biostatistician on clinical trial working groups, collaborating daily with Clinical Leads, Data Managers, and Biomarker scientists.
• Blend pharmacokinetic (PK/PD) and translational biomarker data into trial-level exploratory analyses to identify early safety or efficacy signals.

Qualifications & Skills

• Ph.D. in Biostatistics or Statistics with 6+ years of biotech/pharma experience, ORM.
• 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).
• 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).
• Outstanding written and verbal communication skills, with a proven ability to influence matrixed teams and explain statistical concepts simply.