Associate Director/Director Biostatistics

Verastem Oncology; Needham (MA); On-site; USD 200,000 - 265,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Competitive benefits package

Job summary

The Associate Director/Director, Biostatistics at Verastem Oncology leads statistical activities across multiple clinical studies, partnering with Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to ensure rigorous, well-defined analyses.

Responsibilities include designing analyses, authoring SAPs, supporting regulatory submissions, overseeing CROs, and communicating complex statistical concepts to cross-functional teams, with exposure to NDAs/MAAs and oncology

Qualifications

• PhD or MS with extensive clinical trial experience.
• Knowledge of FDA/EMA/ICH guidelines and regulatory submissions.
• Proficiency in SAS; R preferred.
• Experience with oncology trials is a plus.
• Strong organizational and communication skills.

Responsibilities

• Lead statistical work for multiple clinical studies within a program.
• Formulate and carry out analyses; communicate results cross-functionally.
• Support regulatory submissions and respond to regulatory requests.
• Author or review SAPs, tables, figures, and listings.
• Oversee CROs and ensure quality of results.
• Contribute to clinical study reports and publications.

Skills

Strong communication

Cross-functional work

Statistical methods

Regulatory submissions

Education

PhD in statistics or related field

MS in statistics or equivalent

Tools

SAS

R

Job description

Company Profile:

At Verastem Oncology,weaddressurgent needs of patients living withcancersdriven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance.FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapyfor women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need.We'velaunched thisnovel/novelcombination therapy in the U.S. and are exploringpathways for Europe and Japan. Wecontinueto advance our pipeline of drugstohelp block cancer cell survival, inhibit tumor growth, and overcome treatment resistance.This isan exciting opportunity to shape the future of cancer care and make a meaningful impactinthe lives of patients.

Summary:

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.

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.

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.