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Client:
Location:
bolton, greater manchester, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Views:
3
Posted:
26.06.2025
Expiry Date:
10.08.2025
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Job Description:
Job responsibilities (but not limited to):
Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses. Supports both the Clinical Development portfolio and Strategic Medical Affairs in their support to Affiliates, complying with international, regulatory guidelines, policies, and standards. Directs the operational aspects of statistical work outsourced to CROs.
Manages several projects across more than one therapeutic area.
Attends and presents at external meetings for Statistics (e.g., Investigators Meetings, Regulatory Agencies, Advisory Boards).
Provides qualified 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 and reviews the statistical parts of protocols.
Briefs CROs on conducting statistical analyses of EPD Clinical Development studies, reviews analysis plans, participates in Blind Data Reviews, and approves database lock and unblinding requests. Communicates results and conclusions clearly to ensure correct interpretation.
Supports dossier submissions and responds to statistical questions.
Develops integration plans for internal compound data analyses, ensuring proper execution and data utilization activities like meta-analyses and data explorations.
Manages external statisticians working on clinical trial data analysis, and briefs CROs on deliverables.
Keeps up-to-date with statistical literature, attends conferences, and collaborates with other statisticians to learn new methodologies and maintain expertise.
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