Senior Director Biostatistics

Verastem•Boston, MA

9d•$250,000 - $300,000

About The Position

We are excited to add a senior member to the Verastem Oncology biostatistics team! This role will be responsible for overseeing statistical activities for multiple clinical studies within a clinical development program, serve as a key contributor to study design and protocol development, and conceptualizing and performing analyses of clinical trial data. This is a hands-on position, and the individual will participate in a variety of strategic departmental initiatives as well as cross functional technology development and process improvement initiatives.

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 11 years of relevant clinical trial experience
Knowledge of statistical methods for clinical trials
In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
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

Nice To Haves

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

Responsibilities

Serve as a biostatistics leader within the organization, and manage statistical efforts for multiple clinical studies across a clinical program; provide leadership and guidance to other members of biostatistics and statistical programming team
Formulate, carry out, and oversee statistical analyses of clinical trial data to advance clinical development programs and to facilitate external collaborations; communicate interpretation of results cross-functionally
Lead regulatory submissions as needed including from a biostatistics and programming activities perspective; provide response to regulatory requests independently; ensure applicable understanding of team members of statistical aspects of regulatory interactions
Author protocol sections on statistical methods and review/edit other sections including (but not limited to) endpoints, objectives and assessments, by applying statistical principles
Author or oversee creation of statistical analysis plans for studies and/or ISS/ISEs; author/edit shells for tables, figures and listings
Provide statistical input to independent data monitoring committee (IDMC) and independent review committee (IRC) charters, project management plan, and other study-level documents
Create and manage timelines for SAPs, analysis specifications, and IDMC documents as needed by project/study teams
Conduct statistical modeling to enable robust and efficient statistical designs and to address identified or potential statistical issues arising in studies or programs
Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses; review and approve programming specifications for SDTM and ADaM datasets, pre-specified TLFs and ad-hoc analyses
Support ongoing safety review and IDMC review of the clinical development program/study teams
Perform ad hoc and exploratory statistical analyses as needed
Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
Support the preparation of publications, including manuscripts, posters and oral presentations
Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs