Senior Director Biostatistics

Company Profile:

At Verastem Oncology, we address urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We’ve launched this novel/novel combination therapy in the U.S. and are exploring pathways for Europe and Japan. We continue to advance our pipeline of drugs to help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. This is an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients.

Summary:

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.

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

Qualifications:

• 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

The base salary range ($265,000 - $310,000) provided reflects our current estimate of what we anticipate paying for this position. 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. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.