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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses to support the Clinical Development portfolio and Strategic Medical Affairs, ensuring 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 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. Responsible for selecting appropriate statistical methodologies, defining endpoints, designing studies, and determining sample sizes. Writes and reviews statistical parts of protocols.
6. Briefs CROs on statistical analysis plans, reviews 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 and conclusions to ensure correct interpretation.
7. Supports dossier submissions and addresses statistical questions related to filings.
8. Develops integration plans for internal compound data bases, ensuring proper execution in collaboration with Clinical teams. Utilizes data for knowledge enhancement through data integration and exploration activities, including meta-analyses.
9. Manages external statisticians analyzing EPD clinical trial data and briefs CROs on methodological and statistical deliverables.
10. Reviews statistical literature, attends conferences and courses to maintain high expertise, and collaborates with other statisticians to learn new methodologies.
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