Director, Biostatistics

The role

The Director of Biostatistics will lead statistical strategy, design, and trial-level execution for early-phase oncology clinical trials. This role involves authoring statistical analysis plans, executing complex statistical models, and analyzing data for novel cancer therapies.

What you will do

• Lead statistical design and execution of individual oncology protocols
• Implement and execute trial-level dose-finding methodologies
• Program, validate, and perform statistical analyses for trial data cuts
• Author trial-specific Statistical Analysis Plans
• Design shell tables, listings, and figures
• Write statistical sections of Clinical Study Reports
• Design and build dynamic data visualizations and dashboards
• Translate statistical outputs into visual decks for leadership and investors
• Provide technical oversight to CRO programmers and biostatisticians
• Prepare data packages and statistical rationales for regulatory submissions

Required qualifications

• 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
• Expert knowledge of early oncology endpoints (e.g., DLT, PFS, ORR, RECIST 1.1, Lugano criteria)
• Comfort working in a fast-paced environment with a high volume of early-stage data iterations
• Outstanding written and verbal communication skills

About the company

Treeline Biosciences is a multi-state employer.