Associate Director/Director Biostatistics

Verastem•Needham, MA

About The Position

The Associate Director/Director, Biostatistics is a hands-on statistical leader responsible for statistical activities for multiple clinical studies within a clinical development program. The role partners with Clinical Development, Regulatory Affairs, Medical Affairs, and other development functions to ensure development plans and clinical studies are rigorous and well defined from a statistical and analytical perspective.

Requirements

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.
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; and a positive, collaborative approach.

Nice To Haves

Experience with NDAs, MAAs, and other regulatory submissions is preferred.
Oncology clinical trial experience preferred.

Responsibilities

Lead statistical work for one or more clinical studies within a clinical program and coordinate assigned statistical work and collaborate with programming staff.
Formulate and carry out statistical analyses of clinical trial data to advance clinical development programs and facilitate external collaborations; communicate interpretation of results cross-functionally.
Support regulatory submissions and interactions as needed from a biostatistics and programming perspective; provide responses to regulatory requests; ensure team understanding of the statistical aspects of regulatory interactions.
Contribute to and support authoring of protocol sections on statistical methods and review or edit other sections, including endpoints, objectives, and assessments, by applying statistical principles.
Author or oversee creation of statistical analysis plans for studies 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 enable rigorous and efficient study designs and address identified or potential statistical issues arising in studies or programs.
Review case report form designs to ensure data collection meets study objectives and statistical analysis requirements.
Support ongoing safety review and independent data monitoring committee review for assigned studies.
Perform ad hoc and exploratory statistical analyses as needed.
Contribute to clinical study reports, including authoring statistical sections and interpreting study results.
Support preparation of publications, including manuscripts, posters, and oral presentations.
Oversee CROs performing outsourced statistical activities and quality-control key results generated by CROs.
Communicate complex statistical concepts and analysis results to cross-functional study teams.