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Manager, Statistical Insights
2 months ago
The Manager, Statistics provides statistical expertise to support the research and development organization at AbbVie. Specific areas of work may include clinical trials, patient safety, and global medical affairs.
Key Responsibilities- Provide expertise to design, analysis, and reporting of clinical trials or other scientific research studies.
- Independently develop protocols and/or statistical analysis plans 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 the 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.
- Collaborate with cross-functional team for benefit-risk planning and assessment.
- Contribute to cross-functional development of output specifications to address both pre-planned safety analyses and ad hoc requests.
- Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to characterize the safety profile of AbbVie products, improve efficiencies, and provide consistency across therapeutic areas.
- In collaboration with GMA, Clinical Statistics, Data Sciences, Statistical Programming, and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high-quality, patient-centric evidence and insights to drive decisions.
