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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses, supporting both the Clinical Development portfolio and Strategic Medical Affairs in compliance with international, regulatory guidelines, policies, and standards.
2. Directs the operational aspects of statistical work outsourced to CROs.
3. Manages multiple projects across various therapeutic areas.
4. Attends and presents at external meetings related to statistics, such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
5. Provides qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols, ensuring appropriate statistical methodology and endpoint definitions.
6. Prepares and reviews the statistical components of study protocols.
7. Briefs CROs on statistical analysis conduct, reviews analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures.
8. Approves database lock and requests unblinding for analysis, communicating results clearly to ensure correct interpretation.
9. Supports dossier submissions and responds to statistical questions.
10. Develops integration plans for internal data analysis, ensuring proper execution and data utilization activities like meta-analyses and data explorations.
11. Manages external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
12. Maintains high statistical expertise by reviewing literature, attending conferences, and collaborating with other statisticians to stay updated on new methodologies.
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