Associate Director/Director Biostatistics

Verastem Oncology; Massachusetts; On-site; USD 200,000 - 265,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Competitive benefits

Job summary

Verastem Oncology seeks an Associate Director, Biostatistics to lead statistical activities for one or two clinical studies and collaborate with cross-functional teams to ensure rigorous study design and analyses.

The role includes authoring SAPs, overseeing TFLs, supporting regulatory submissions, and contributing to clinical study reports, publications, and CRO management. A PhD with extensive trial experience or an MS with substantial experience is required.

Qualifications

• PhD in statistics or a related field with at least 8 years of relevant clinical trial experience, or MS with at least 10 years of relevant clinical trial experience.
• 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.

Responsibilities

• Lead statistical work for one or two studies, support other studies as needed, and serve as the statistical point of contact.
• Perform and assist with formulation of statistical analyses of clinical trial data to advance clinical development programs and facilitate external collaborations; communicate interpretation of results cross-functionally.
• Execute predefined statistical regulatory strategy and 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.
• Execute statistical aspects of data monitoring committee charters, project management plans, and other study-level documents.
• Ensure the quality of 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.
• Provide input into 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.
• Collaborate with CROs performing outsourced statistical activities and support quality control of key results generated by CROs.
• Communicate complex statistical concepts and analysis results to cross-functional study teams.

Skills

Strong communication

Cross-functional teamwork

Statistical expertise

Regulatory knowledge

Statistical programming

Education

PhD in statistics or related field

MS in statistics or equivalent

Tools

SAS

R

Job description

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:

The Associate Director, Biostatistics is a hands-on statistical leader responsible for statistical activities for one or two clinical studies and supporting additional studies as needed. 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.

Responsibilities:

• Lead statistical work for one or two studies, support other studies as needed, and serve as the statistical point of contact.
• Perform and assist with formulation of statistical analyses of clinical trial data to advance clinical development programs and facilitate external collaborations; communicate interpretation of results cross-functionally.
• Execute pre-defined statistical regulatory strategy and 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.
• Execute statistical aspects of data monitoring committee charters, project management plans, and other study-level documents.
• Ensure the quality of 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.
• Provide input into 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.
• Collaborate with CROs performing outsourced statistical activities and support quality control of key results generated by CROs.
• Communicate complex statistical concepts and analysis results to cross-functional study teams.

Qualifications:

• 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; and a positive, collaborative approach.
• Oncology clinical trial experience preferred.

The base salary range ($200,000 - $265,000) 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.