Social network you want to login/join with:
Job responsibilities (but not limited to):
1. Coordinates, provides, and delivers methodological and statistical expertise and/or analyses, supporting both Clinical Development and Strategic Medical Affairs in compliance with international, regulatory guidelines, policies, and standards.
2. Oversees the operational aspects of statistical work outsourced to CROs.
3. Manages multiple projects across various therapeutic areas.
4. Attends and presents at external meetings such as Investigator Meetings, Regulatory Agencies, and Advisory Boards.
5. Provides statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols.
6. Ensures appropriate statistical methodology and endpoint definitions during clinical study design and sample size determination.
7. Prepares and reviews the statistical components of protocols.
8. Briefs CROs on statistical analysis conduct, 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 to ensure correct interpretation.
10. Supports dossier submissions and addresses statistical questions related to filings.
11. Develops strategic and detailed integration plans for internal data analysis, ensuring proper execution.
12. Utilizes data effectively for knowledge enhancement through data integration and exploration activities like meta-analyses.
13. Manages external statisticians working on clinical trial data analysis and briefs CROs on deliverables.
14. Reviews current statistical literature, attends conferences and courses to maintain high expertise and proficiency, and collaborates with other statisticians to learn new methodologies.
J-18808-Ljbffr