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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses. Supports both the Clinical Development portfolio and Strategic Medical Affairs in their support to Affiliates, complying with international, regulatory guidelines, policies, and standards. Manages the operational aspects of statistical work outsourced to CROs.
2. Manages multiple projects across various therapeutic areas.
3. Attends and presents at external meetings for Statistics, such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
4. Provides qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols. Responsible for selecting appropriate statistical methodologies, defining endpoints, and determining sample sizes. Writes and reviews the statistical sections of protocols.
5. Briefs CROs on statistical analysis conduct for EPD Clinical Development studies, reviews statistical analysis plans, participates in Blind Data Reviews, and reviews study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Clarifies and communicates results to ensure correct interpretation.
6. Supports dossier submissions and responds to statistical questions related to the filings.
7. Develops integrated analysis plans for internal compound databases, collaborating with Clinical to ensure proper execution. Explores data to enhance knowledge of compounds through data integration and meta-analyses.
8. Manages external statisticians analyzing EPD clinical trial data and briefs CROs on deliverables.
9. Reviews statistical literature, attends conferences and courses to maintain high statistical expertise, and collaborates with other statisticians to learn new methodologies.
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