Associate Director – Biostatistics

Verastem Oncology

. Lead statistical work for one or more clinical studies within a clinical program .

Posted 9/16/2026full-timeNeedham • Massachusetts • United StatesSenior💰 $200,000 - $265,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical analysis and clinical trial design, with a strong focus on regulatory submissions and compliance with FDA, EMA, and ICH guidelines. Proficient in statistical programming using SAS and R, with a proven ability to communicate complex statistical concepts effectively across cross-functional teams.

Highest-signal resume keywords

PhD In Statistics Or Related FieldStatistical Programming (SAS Required, R Preferred)Clinical Trial Design ExperienceKnowledge Of FDA, EMA, And ICH RegulationsStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical AnalysisStatistical ModelingStatistical Methods For Clinical TrialsStatistical Analysis PlansData Monitoring Committee SupportAd Hoc Statistical AnalysesClinical Study ReportsProtocol AuthoringQuality Control Of CRO ResultsExploratory Statistical Analyses

Soft Skills

Strong Organizational SkillsAnalytical SkillsProblem-Solving SkillsCollaborative ApproachAbility To Manage Changing Priorities

Industry Keywords

Clinical TrialsRegulatory SubmissionsNDAMAAOncology Clinical Trials

About the role

Key responsibilities & impact

Lead statistical work for one or more clinical studies within a clinical program
Coordinate assigned statistical work and collaborate with programming staff
Formulate and carry out statistical analyses of clinical trial data
Communicate interpretation of results cross-functionally
Support regulatory submissions and interactions, including responses to regulatory requests
Author and review protocol sections on statistical methods, endpoints, objectives, and assessments
Author or oversee statistical analysis plans and integrated summaries
Author or edit shells for tables, figures, and listings
Provide statistical input to data monitoring committee charters, project management plans, and other study-level documents
Manage timelines for assigned statistical deliverables
Conduct statistical modeling to support study designs and address statistical issues
Review case report form designs
Support ongoing safety review and independent data monitoring committee review
Perform ad hoc and exploratory statistical analyses
Contribute to clinical study reports, including statistical sections and interpretation of results
Support preparation of publications, including manuscripts, posters, and oral presentations
Oversee CROs performing outsourced statistical activities and quality-control key CRO-generated results
Communicate complex statistical concepts and analysis results to cross-functional study teams

Requirements

What you’ll need

PhD in statistics or a related field with at least 8 years of relevant clinical trial experience, or MS in statistics or equivalent with at least 10 years of relevant clinical trial experience
Strong communication skills and ability to work effectively with cross-functional teams
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 preferred
Proficiency in statistical programming; SAS is required and R is preferred
Experience with clinical trial design
Strong organizational, analytical, and problem-solving skills
Ability to manage changing priorities in a fast-paced environment
Positive, collaborative approach
Oncology clinical trial experience preferred

Benefits

Comp & perks

Annual bonus
Equity compensation
Competitive benefits package