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Location:
portsmouth, hampshire, 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 multiple projects across various therapeutic areas.
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. Responsible for statistical methodology, endpoint definitions, and sample size determination in clinical study design. Writes and reviews statistical parts of protocols.
Briefs CROs on statistical analysis conduct, reviews analysis plans, participates in Blind Data Reviews, reviews study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Communicates results and conclusions clearly to ensure correct interpretation.
Supports dossier submissions and addresses statistical questions.
Develops integration plans for internal data analysis, ensuring proper execution, and leveraging data for knowledge enhancement through meta-analyses and explorations.
Manages external statisticians analyzing clinical trial data, briefs CROs on deliverables.
Keeps up-to-date with statistical literature, attends conferences, and collaborates with other statisticians to learn new methodologies, maintaining high expertise.
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