The Manager, Statistics provides statistical expertise to support the research and development organization. Specific areas of work may include clinical trials, patient safety, and global medical affairs. The Manager works independently in partnership with experts in multiple disciplines to advance medicines to our patients.
Responsibilities:
- Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies. Independently develop protocols and/or statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation) with details for programming implementation. Implement sound statistical methodology in scientific investigations.
- Identify scientifically appropriate data collection instruments. Identify and report data issues or violations of study assumptions. Provide programming specifications for derived variables and analysis datasets. Partner with Data Science 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. Collaborate in publication of scientific research. Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures. Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.
- Work collaboratively with multifunction teams. Clearly explain statistical concepts to non-statisticians. Provide responses to questions, and pursue analyses suggested by data. Support communications between assigned product team(s) and functional management. Build/drive cross-functional relationships and collaboration.