Verastem
Senior Director Biostatistics
Boston, Massachusetts · Director
Sponsorship not specified$250k-$300kDetected 27 days ago
StatisticsProject ManagementProcess ImprovementClinical TrialsFDA RegulatorySASExperimental DesignLeadershipCommunicationProblem SolvingPublic SpeakingOrganizational SkillsBiostatistics
About the role
- 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.
- Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics.
Responsibilities
- Serve as a biostatistics leader within the organization, and manage statistical efforts for multiple clinical studies across a clinical program
- Lead regulatory submissions as needed including from a biostatistics and programming activities perspective
- 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
- 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
- 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
- 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
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
- 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
- The base salary range ($250,000 - $300,000) provided reflects our current estimate of what we anticipate paying for this position.
Nice to have
- Experience with NDAs, MAAs and other regulatory submissions is a plus
- Proficient in statistical programming (SAS is required and R is a plus)
- Oncology clinical trial experience preferred
Compensation
- The base salary range ($250,000 - $300,000) provided reflects our current estimate of what we anticipate paying for this position.
Company info
- We are excited to add a senior member to the Verastem Oncology biostatistics team!
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This listing is sourced directly from Verastem's careers page and normalized into a canonical job model.