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Client:
Location:
sheffield, south yorkshire, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Views:
4
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. Manages the operational aspects of statistical work outsourced to CROs.
Manages multiple projects across different therapeutic areas.
Attends and presents at external statistical meetings (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 statistical sections of protocols.
Briefs CROs on statistical analysis plans, reviews analysis outputs, and approves database lock and unblinding procedures. Clarifies and communicates results and conclusions to ensure correct interpretation.
Supports dossier submissions and addresses statistical questions related to filings.
Develops integration plans for internal data analyses, ensuring proper execution and leveraging data for knowledge enhancement through meta-analyses and data exploration.
Manages external statisticians working on clinical trial analyses, providing guidance on methodological and statistical deliverables.
Keeps up-to-date with statistical literature, attends conferences, and collaborates with other statisticians to learn new methodologies. Maintains high expertise in statistical and clinical content.
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