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.
