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Senior Manager, Biostatistics
Job in
Greater London, London, Greater London, W1B, England, UK
Listed on 2026-02-17
Listing for:
Discover International
Full Time
position Listed on 2026-02-17
Job specializations:
-
IT/Tech
Data Security, Big Data, Data Scientist
Job Description & How to Apply Below
- Lead the development and implementation of advanced statistical methodologies across clinical programs.
- Contribute to innovative trial designs including adaptive designs, Bayesian approaches, seamless Phase II/III designs, enrichment strategies, and interim analyses
. - Provide expertise in estimands framework (ICH E9 R1) and support alignment of objectives, endpoints, and analysis strategies.
- Advise on multiplicity control, missing data strategies, and sensitivity analyses.
- Lead statistical input into clinical development plans and protocol design.
- Author and review statistical sections of protocols, SAPs, and regulatory documents.
- Oversee statistical analyses and outputs from CROs.
- Ensure high-quality deliverables in compliance with ICH, GCP, and regulatory expectations.
- Contribute to regulatory interactions (e.g., Scientific Advice, MHRA, EMA, FDA).
- Prepare briefing documents and represent Biostatistics in meetings with health authorities.
- Stay current with emerging statistical guidance and industry best practices.
- MSc or PhD in Statistics, Biostatistics, or related quantitative discipline.
- Minimum 8+ years of experience in biostatistics within biotech or pharmaceutical development.
- Strong hands‑on experience in clinical trial methodology and advanced statistical techniques.
- Demonstrated experience supporting regulatory submissions and authority interactions.
- Proficiency in SAS and/or R.
- Experience managing or overseeing CROs preferred.
- Excellent communication skills and ability to explain complex methodology to non-statisticians.
Position Requirements
10+ Years
work experience
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