Director, Biostatistics — Oncology Clinical Trials Lead (Equity Eligible)

Verastem Oncology; Needham (MA); On-site; USD 200,000 - 265,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Competitive benefits package

Job summary

The Associate Director/Director, Biostatistics at Verastem Oncology leads statistical activities across multiple clinical studies, partnering with Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to ensure rigorous, well-defined analyses.

Responsibilities include designing analyses, authoring SAPs, supporting regulatory submissions, overseeing CROs, and communicating complex statistical concepts to cross-functional teams, with exposure to NDAs/MAAs and oncology

Qualifications

• PhD or MS with extensive clinical trial experience.
• Knowledge of FDA/EMA/ICH guidelines and regulatory submissions.
• Proficiency in SAS; R preferred.
• Experience with oncology trials is a plus.
• Strong organizational and communication skills.

Responsibilities

• Lead statistical work for multiple clinical studies within a program.
• Formulate and carry out analyses; communicate results cross-functionally.
• Support regulatory submissions and respond to regulatory requests.
• Author or review SAPs, tables, figures, and listings.
• Oversee CROs and ensure quality of results.
• Contribute to clinical study reports and publications.

Skills

Strong communication

Cross-functional work

Statistical methods

Regulatory submissions

Education

PhD in statistics or related field

MS in statistics or equivalent

Tools

SAS

R

Job description

The Associate Director/Director, Biostatistics at Verastem Oncology leads statistical activities across multiple clinical studies, partnering with Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to ensure rigorous, well-defined analyses.

Responsibilities include designing analyses, authoring SAPs, supporting regulatory submissions, overseeing CROs, and communicating complex statistical concepts to cross-functional teams, with exposure to NDAs/MAAs and oncology