Director, Biostatistics

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. 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. This position is classified as exempt.

The anticipated annual base salary range for candidates who will work in Watertown is $226,425 - $257,000. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, and other factors.

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