Lead Biostatistician, Early-Phase Oncology Trials

Treeline; Watertown (MA); On-site; USD 180,000 - 300,000; Full time

Job summary

Treeline is seeking a Director of Biostatistics to lead the statistical strategy, design, and trial-level execution for early-phase oncology trials (Phase I/II). The role oversees SAPs, complex modeling, and real-time data analyses to support PoC development and IND submissions.

The ideal candidate will have a PhD or MS with extensive biotech/pharma experience, expert skills in R and SAS, and a proven ability to communicate complex results to leadership and study teams.

Qualifications

• PhD in Biostatistics or Statistics with 6+ biotech/pharma years OR MS with 8+ biotech/pharma years.
• Minimum 3 years hands-on design, modeling and analysis of early-phase oncology trials (Phase I/II).
• Proven track record from protocol design to CSR for oncology trials.

Responsibilities

• Lead statistical design and execution of oncology trial protocols, including sample size, randomization, and adaptive design simulations.
• Implement dose-finding methods such as BOIN and cohort expansion models.
• Program, validate, and perform analyses for trial data cuts, Safety Review Committees, and Dose Escalation Meetings.
• Author SAPs, design tables/listings/figures, and write statistical sections of CSRs.
• Design data visualizations and dashboards (e.g., R/Shiny) to track dose escalation, safety signals, and biomarker trends.
• Translate statistical outputs into high-impact visual decks for executives and boards.
• Provide technical oversight to CRO programmers/biostatisticians for trial deliverables.
• Prepare data packages and statistical rationales for IND submissions and regulatory filings.

Skills

R

SAS

Shiny

Communication

Education

PhD in Biostatistics/Statistics

MS in Biostatistics/Statistics

Tools

R

SAS

Shiny

Job description

Treeline is seeking a Director of Biostatistics to lead the statistical strategy, design, and trial-level execution for early-phase oncology trials (Phase I/II). The role oversees SAPs, complex modeling, and real-time data analyses to support PoC development and IND submissions.

The ideal candidate will have a PhD or MS with extensive biotech/pharma experience, expert skills in R and SAS, and a proven ability to communicate complex results to leadership and study teams.