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Location:
crawley, west sussex, 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. Directs the operational aspects of statistical work outsourced to CROs.
Manages several projects across multiple 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 the statistical part of protocols.
Briefs CROs on statistical analysis of EPD Clinical Development studies, reviews analysis plans, participates in Blind Data Reviews, reviews study report tables, listings, and figures. Approves database lock and requests unblinding for analysis. Clarifies and communicates results and conclusions to ensure correct interpretation.
Supports dossier submissions and responds to statistical questions.
Writes strategic and detailed integration plans for internal data analysis, ensuring proper execution and data utilization activities like meta-analyses and data explorations.
Manages external statisticians analyzing clinical trial data, briefs CROs on deliverables.
Reviews statistical literature, attends conferences, and courses to maintain high expertise and proficiency. Collaborates with other statisticians to learn new methodologies and stays updated on statistical and clinical content.
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