Senior Director, Biostatistics

Verastem Oncology

. Serve as a biostatistics leader and manage statistical efforts for multiple clinical studies across a clinical program .

Posted 9/16/2026full-timeNeedham • Massachusetts • United StatesSenior💰 $265,000 - $310,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics leadership, statistical analysis, and regulatory submissions for clinical trials, with a strong focus on communication and collaboration across cross-functional teams.

Highest-signal resume keywords

PhD In Statistics Or Related FieldStatistical Programming (SAS Required, R Plus)Knowledge Of FDA, EMA And ICH RegulationsClinical Trial Design ExperienceOncology Clinical Trial Experience Preferred

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisStatistical ModelingProtocol Statistical Methods AuthoringStatistical Analysis Plans (SAPs)CRF Design ReviewAd Hoc Statistical AnalysesClinical Study Report ContributionRegulatory Submission ExperienceTimelines ManagementStatistical Input To IDMC And IRC Charters

Soft Skills

Good Communication SkillsGood Organizational SkillsAnalytical And Problem Solving SkillsPositive And Collaborative Attitude

Industry Keywords

Clinical TrialsNDAMAACRO ManagementIDMCTLFsADaMSDTMExploratory Statistical AnalysesFast-Paced Environment

About the role

Key responsibilities & impact

Serve as a biostatistics leader and manage statistical efforts for multiple clinical studies across a clinical program
Provide leadership and guidance to biostatistics and statistical programming team members
Formulate, carry out, and oversee statistical analyses of clinical trial data
Communicate interpretation of results cross-functionally
Lead regulatory submissions and independently respond to regulatory requests
Author protocol statistical methods sections and review endpoints, objectives, and assessments
Author or oversee statistical analysis plans and author/edit table, figure, and listing shells
Provide statistical input to IDMC and IRC charters, project management plans, and other study-level documents
Create and manage timelines for SAPs, analysis specifications, and IDMC documents
Conduct statistical modeling for study design and statistical issues
Review CRF designs and approve programming specifications for SDTM, ADaM, TLFs, and ad-hoc analyses
Support ongoing safety and IDMC reviews
Perform ad hoc and exploratory statistical analyses
Contribute to clinical study reports and author statistical sections
Support publications including manuscripts, posters, and oral presentations
Oversee CROs and QC key results from outsourced statistical activities

Requirements

What you’ll need

PhD in statistics or a related field with at least 13 years of relevant clinical trial experience, or MS in statistics or equivalent with at least 15 years of relevant clinical trial experience
Knowledge of statistical methods for clinical trials
In-depth knowledge of FDA, EMA and ICH regulations and guidelines
Experience with NDAs, MAAs and other regulatory submissions is a plus
Proficient in statistical programming; SAS is required and R is a plus
Experience with clinical trial design
Good communication skills and ability to work with cross-functional study teams
Good organizational skills sufficient to multi-task in an extremely fast-paced environment with changing priorities
Good analytical and problem solving skills
Positive and collaborative attitude
Oncology clinical trial experience preferred

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package