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Director Biostatistician, Watford, Hertfordshire
Client:
Location: Watford, Hertfordshire, United Kingdom
Job Category: Other
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EU work permit required:
Yes
Job Views: 3
Posted:
26.06.2025
Expiry Date:
10.08.2025
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 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 statistical analysis conduct, reviews analysis plans, participates in Blind Data Reviews, and approves database lock and unblinding requests. Clarifies and communicates results and conclusions for correct interpretation.
Supports dossier submissions and responds to statistical questions.
Develops integration plans for internal data analysis, ensuring proper execution, and exploits data potential through integration and data utilization activities like meta-analyses and explorations.
Manages external statisticians analyzing clinical trial data 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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