Job responsibilities (but not limited to):
1. Coordinate, provide, and deliver methodological and statistical expertise and analyses to support the Clinical Development portfolio and Strategic Medical Affairs in compliance with international, regulatory guidelines, policies, and standards.
2. Manage the operational aspects of statistical work outsourced to CROs.
3. Handle multiple projects across various therapeutic areas.
4. Attend and present at external meetings such as Investigators Meetings, Regulatory Agencies, and Advisory Boards.
5. Provide qualified statistical and methodological support to EPD, including input into Clinical Development Plans and study protocols, ensuring appropriate methodology and endpoint definitions.
6. Draft and review statistical parts of study protocols and oversee statistical analysis conducted by CROs, including review of analysis plans, study report tables, listings, and figures.
7. Approve database lock and unblinding procedures, and communicate results and conclusions clearly to ensure correct interpretation.
8. Support dossier submissions and respond to statistical queries related to the filings.
9. Develop and execute integration plans for internal compound data, facilitating data analysis and knowledge enhancement through meta-analyses and data explorations.
10. Manage external statisticians working on clinical trial data analysis and coordinate with CROs on deliverables.
11. Stay updated with statistical literature, attend conferences, and participate in courses to maintain and enhance statistical expertise and clinical content knowledge.
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