Senior Manager, Statistics
Senior Manager, Statistics Remote | United States Salary: $137,000–$215,270 per year About the Opportunity A leading global pharmaceutical organization is seeking a Senior Manager, Statistics to provide statistical leadership and expertise across oncology clinical development programs. The role supports the design, analysis, and interpretation of clinical trials, helping inform quantitative decision-making throughout the drug development process. This position works with global cross-functional teams and offers the opportunity to contribute to study design, regulatory submissions, statistical methodology, and innovative approaches to clinical trial analysis.
Key Responsibilities
Provide statistical expertise in the design, analysis, and interpretation of clinical trials. Represent the statistics function on global cross-functional development teams. Support oncology programs and compound-level decision-making through rigorous statistical analysis. Develop and review study synopses, protocols, statistical analysis plans, clinical study reports, and regulatory submission documents. Lead compound-level analysis and reporting activities, including oversight of statisticians and statistical programmers. Coordinate statistical deliverables to ensure high-quality, timely, and cost-effective execution. Apply innovative statistical methodologies and advanced clinical study designs to optimize trial strategies. Monitor developments in statistical methodology and contribute to the implementation of emerging approaches. Provide oversight of statistical programming and analysis activities, including SDTM, ADaM, tables, figures, and listings. Ensure statistical analyses and outputs meet applicable regulatory and industry standards. Collaborate with internal and external resources to support clinical development and submission activities.
Requirements
Ph.D. in Mathematics, Biostatistics, Statistics, or a related quantitative discipline. At least 1 year of relevant professional experience. Experience with innovative clinical study designs, complex analytical methodologies, and inferential statistics. Ability to conduct mathematical and statistical simulations supporting clinical trial development. Hands-on experience using statistical programming languages and software such as SAS, R, or MATLAB. Strong understanding of statistical analysis within the pharmaceutical or clinical development environment. Extensive knowledge of FDA and ICH regulations and industry standards governing clinical trial design, conduct, analysis, and regulatory submissions. Experience providing oversight of statistical activities and deliverables, including SDTM, ADaM, TFLs, and related analysis outputs. Strong analytical, communication, collaboration, and project leadership skills. Compensation & Benefits The expected annual salary range is $137,000–$215,270 , with actual compensation determined based on relevant experience, qualifications, location, and other applicable factors. Eligible employees may have access to a comprehensive benefits package that can include: Medical, dental, and vision insurance 401(k) retirement plan with employer match Short- and long-term disability coverage Life insurance Tuition reimbursement Paid volunteer time Paid holidays Paid vacation and sick leave Employee wellbeing programs Potential short- and/or long-term incentive opportunities Remote work is available from anywhere in the United States.