Senior Manager - Statistics - Oncology (Hybrid)
Core
Provides statistical leadership to support research and development, advancing medicines to patients through clinical trials and scientific research programs.
Role type
Senior Manager, Statistics (Oncology)
Builds
Clinical trial protocols, statistical analysis plans, and regulatory submission strategies for oncology medicines.
Domain
Pharmaceutical / Biotechnology / Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Statistical leadership, clinical trial design and analysis, protocol development, statistical programming specifications, data collection instrument design, cross-functional collaboration, regulatory submission strategy, data presentation and inference, scientific publication support, team management.
Preferred skills
Oncology-specific trial experience, submission experience, novel statistical methodology development.
Technologies
Statistical software (implied), data analysis tools
Responsibilities
Support regulatory submission and product life-cycle management strategy planning and implementation. Provide statistical leadership for design, analysis and reporting for clinical trials or other scientific research programs. Independently develop protocols and statistical analysis plans. Lead in identifying scientifically appropriate data collection instruments. Guide Data Science and other functions in preparing for database lock. Independently perform statistical analyses as per the analysis plan. Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to agreed-upon timelines. Identify and anticipate issues arising in the study design, conduct and propose scientifically sound approaches. Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology. Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
Seniority
Senior Manager, hands-on IC with leadership responsibilities