Director Biostatistics

Treeline; Watertown (MA); On-site; USD 210,000 - 320,000; Full time

Job summary

Treeline seeks a Director of Biostatistics to lead statistical strategy, design, and trial-level execution for early-phase oncology trials (Phase I/II). You will author SAPs, execute complex models, and analyze data for novel cancer therapies, ensuring rigorous study design from FIH dose escalation to PoC.

You will collaborate closely with Clinical Leads, Data Managers, and Biomarker scientists, oversee CRO programming, and contribute to regulatory submissions with clear statistical rationale.

Qualifications

• PhD with 6+ years biotech/pharma experience OR MS with 8+ years biotech/pharma experience.
• Minimum 3 years hands-on experience designing, modeling, and analyzing early-phase oncology trials (Phase I/II).
• Proven track record taking oncology trials from protocol design to CSR.

Responsibilities

• Trial Design & Execution: lead statistical design and execution of oncology protocols, including sample size, randomization, and adaptive designs.
• Statistical Modeling: implement dose-finding methods (e.g., BOIN) and cohort expansion models.
• Analysis & Programming: program, validate, and perform analyses for trial data cuts and CSR statistics.
• SAPs & Output: author SAPs, design shell tables/listings/figures, and write statistical sections of CSRs.
• Visual Reporting: create dynamic visuals and dashboards (R/Shiny) to track dose escalation, safety signals, and biomarkers.
• Translate complex outputs into high-impact visuals for executives and advisory boards.
• CRO Management: oversee CRO programmers and biostatisticians ensuring quality and accuracy.
• Regulatory Submissions: prepare data packages and statistical rationales for IND submissions.

Skills

Biostatistics expertise

Trial design

Data analysis

R programming

SAS programming

Shiny/dynamic visuals

Education

PhD in Biostatistics or Statistics

MS in Biostatistics or Statistics

Tools

R

SAS

Shiny

Job description

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).
• 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.
• 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.

Qualifications & Skills

Education & Experience

• 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.

Technical & Soft Skills

• 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).
• Comfort working in a fast-paced environment with a high volume of early-stage data iterations.
• Outstanding written and verbal communication skills, with a proven ability to influence matrixed teams and explain statistical concepts simply.