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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. Responsible for selecting appropriate statistical methodologies and defining endpoints in clinical study designs, including sample size calculations. Writes and reviews the statistical sections of protocols.
6. Briefs CROs on the conduct of statistical analyses 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. Collaborates with clinicians to interpret and communicate results accurately.
7. Supports dossier submissions and addresses statistical questions related to filings.
8. Develops strategic and detailed integration plans for internal compound data analysis in collaboration with Clinical, ensuring proper execution. Explores data to enhance understanding of compounds through data integration and activities like meta-analyses.
9. Manages external statisticians working on analysis of EPD clinical trial data and briefs CROs on methodological and statistical deliverables.
10. Reviews statistical literature, attends conferences and courses to maintain high statistical expertise, and collaborates with other statisticians to stay updated on new methodologies and clinical content expertise.
This job posting is active and not expired.
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