Director of Biostatistics — Early-Phase Oncology Strategy

ClinLab Solutions Group; Massachusetts; On-site; USD 180,000 - 240,000; Full time

Job summary

ClinLab Solutions Group is seeking an experienced biostatistics leader to drive statistical strategy for early-phase oncology trials. You will design, model, and analyze Phase I/II studies and author analysis plans, ensuring scientific rigor in developing novel cancer therapies.

You will lead dose-finding design, adaptative methods, and collaborate across cross-functional teams, delivering robust statistical outputs and regulatory-ready documentation.

Qualifications

• Ph.D. in Biostatistics or Statistics with 6+ years biotech/pharma experience, or MS with 8+ years.
• Minimum 3 years designing, modeling, and analyzing early-phase oncology trials (Phase I/II).
• Leading oncology trials from protocol design through final clinical study report.
• Advanced programming in R and SAS with trial simulations and visualization tools such as Shiny.

Responsibilities

• Lead statistical design and execution of early-phase oncology trials, including sample size and randomization.
• Implement dose-finding methods like BOIN and cohort expansion models for trial analysis.
• Author and validate statistical analysis plans and study reports.
• Develop dynamic data visualizations and dashboards to monitor dose escalation and biomarkers.
• Translate statistical outputs into clear visuals for leadership and committees.
• Ensure CDISC SDTM/ADaM data standards and oversee external vendors.
• Prepare statistical data packages for regulatory submissions (IND filings).

Skills

R

SAS

Shiny

Statistical modeling

Bayesian design

Data visualization

Communication skills

Cross-functional leadership

Education

PhD in Biostatistics or Statistics

MS in Biostatistics or Statistics

Tools

R

SAS

Shiny

Job description

ClinLab Solutions Group is seeking an experienced biostatistics leader to drive statistical strategy for early-phase oncology trials. You will design, model, and analyze Phase I/II studies and author analysis plans, ensuring scientific rigor in developing novel cancer therapies.

You will lead dose-finding design, adaptative methods, and collaborate across cross-functional teams, delivering robust statistical outputs and regulatory-ready documentation.