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Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or analyses. Supports both the Clinical Development portfolio and Strategic Medical Affairs, ensuring compliance with international, regulatory guidelines, policies, and standards. Manages 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 Investigator Meetings, Regulatory Agencies, and Advisory Boards.
4. Provides statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols. Ensures appropriate statistical methodology and endpoint definitions in clinical study design and sample size determination. Writes or reviews the statistical parts of protocols.
5. Briefs CROs on conducting statistical analyses of 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. Communicates results and conclusions clearly to ensure correct interpretation.
6. Supports dossier submissions and addresses statistical questions related to filings.
7. Develops strategic and detailed integration plans for internal data analysis in collaboration with Clinical, ensuring proper execution. Explores data to enhance knowledge of compounds through data integration and activities like meta-analyses.
8. Manages external statisticians working on analysis of clinical trial data. Briefs CROs on methodological and statistical deliverables.
9. Reviews current statistical literature, attends conferences and courses to maintain high expertise, and collaborates with other statisticians to learn new methodologies. Keeps updated on statistical and clinical content expertise.
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