Director, Biostatistics

The Importance of the Role

The person in this position will serve as a Lead Study Statistician, taking ownership of the statistical strategy and execution for assigned clinical studies from protocol development through database lock, data analysis, interpretation, and reporting. As the clinical development portfolio advances, the individual will progressively assume responsibility as the Program Statistical Lead, providing strategic statistical leadership across studies and development stages and partnering with Clinical Development and senior leadership on key program decisions.

The Opportunity to Make a Difference

• Provide end-to-end statistical leadership for assigned clinical trials, from study design and protocol development through analysis, interpretation, and reporting.
• Partner closely with cross-functional teams to ensure scientifically rigorous study designs, high-quality analyses, and successful execution of statistical deliverables.
• Lead the statistical design of clinical trials, including endpoint strategy, sample size, randomization, interim analyses, and other key methodological considerations.
• Provide hands-on expertise in adaptive trial design, including evaluation, implementation, and interpretation of innovative approaches to optimize clinical development efficiency and decision-making.
• As the clinical development portfolio matures, progressively assume the role of Program Statistical Lead.
• Provide strategic statistical leadership across the clinical development program, ensuring alignment of study designs, methodologies, analyses, and evidence across development stages.
• Partner with Clinical Development and senior leadership to guide key program decisions, pivotal study strategy, integrated analyses, and regulatory strategy.
• Provide statistical leadership and hands-on support for regulatory submissions, including pivotal analyses, submission documents, analysis datasets, and responses to regulatory inquiries.
• Contribute to and, as appropriate, lead statistical discussions with FDA, EMA, and other health authorities, ensuring robust and defensible statistical strategies throughout regulatory review.
• Partner closely with Clinical Development, Clinical Operations, Data Management, Medical, Regulatory, Statistical Programming, and other functions to drive scientifically rigorous and operationally feasible clinical development strategies.
• Serve as a trusted statistical advisor, clearly communicating complex statistical concepts and influencing cross-functional decisions through sound judgment and collaboration.
• Provide statistical oversight and direction to CROs and external vendors while retaining overall accountability for statistical strategy, methodology, interpretation, and scientific quality.
• Critically review deliverables, ensure adherence to study requirements and timelines, and proactively resolve statistical issues to support high-quality clinical trial execution.
• Maintain hands-on expertise in R and/or SAS to independently develop, review, troubleshoot, and validate statistical analyses, outputs, and associated documentation.
• Provide technical oversight of statistical programming and analysis datasets while ensuring robust implementation of statistical methodologies and data standards.
• Contribute to building and advancing the Biostatistics function through development of statistical standards, best practices, processes, and capabilities.
• Mentor and develop statisticians and statistical programmers while contributing to hiring, resource planning, and team growth as the organization expands.

More about You

• Ph.D. (strongly preferred) in Statistics / Biostatistics with 9+ years, or a Master’s degree in Statistics / Biostatistics with 10+ years of progressive biostatistics experience in the pharmaceutical or biotechnology industry, including demonstrated technical expertise and hands-on experience applying advanced statistical methodologies.
• Candidates with a Master’s degree must demonstrate a strong track record of independently applying advanced statistical methods to complex biostatistical problems.
• Candidates whose experience is primarily as a CRO/vendor statistician providing statistical services to sponsors, without meaningful sponsor-side ownership of clinical development studies, will not meet the core experience requirement.
• At least 8 years of substantial, direct clinical trial experience, preferably spanning multiple phases of clinical development.
• Demonstrated experience leading the statistical design, execution, analysis, reporting, and regulatory support of clinical trials as a study statistician, lead statistician, or equivalent statistical lead within a sponsor organization, preferably including Phase 2 and Phase 3/pivotal studies.
• Strong expertise in clinical trial methodology and statistical principles, including adaptive designs, sample size determination, randomization, interim analyses, multiplicity, estimands, missing data, sensitivity analyses, and subgroup analyses.
• Strong hands-on statistical programming skills in R and/or SAS, with experience developing and reviewing SAPs, TFL specifications, integrated analyses, CSRs, and regulatory submission materials.
• Strong understanding of GCP and applicable statistical and regulatory guidance.
• Excellent written and verbal communication skills.
• Demonstrated ability to work effectively in a cross-functional, collaborative environment.
• Ability to operate independently, prioritize competing demands, and make sound statistical decisions with limited supervision.
• Enthusiasm for learning and harnessing modern AI tools and workflows to enhance analytical productivity and scientific insight.