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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. Manages the operational aspects of statistical work outsourced to CROs.
3. Handles multiple projects across various therapeutic areas.
4. Attends and presents at external meetings for 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.
6. Ensures appropriate statistical methodology and endpoint definitions in clinical study designs and determines sample sizes.
7. Prepares and reviews the statistical components of protocols.
8. Briefs CROs on conducting statistical analyses of EPD Clinical Development studies, reviews analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures.
9. Approves database lock and requests unblinding for analysis, and communicates results and conclusions clearly.
10. Supports dossier submissions and responds to statistical queries.
11. Develops integration plans for internal data analysis, ensuring proper execution, and exploits data potential through meta-analyses and data explorations.
12. Manages external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
13. Keeps up-to-date with statistical literature, attends conferences and courses, and collaborates with colleagues to learn new methodologies.
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