Senior Manager, Biostatistics
UK Visa Sponsorship Analytics
Analytics are greyed out due to low classification confidence (33.0%).
Occupation Type
Actuaries, economists and statisticians
Occupation Code Skill LevelHigher Skilled
Sponsorship Salary Threshold
£55,100
(£28.26 per hour)
Occupation rate applies
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Description
Key Responsibilities:
Statistical Strategy & Methodology
- 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.
Clinical Development Support
- 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.
Regulatory & External Engagement
- Contribute to regulatory interactions (e.g., Scientific Advice, MHRA, EMA, FDA).
- Prepare briefing documents and represent Biostatistics in meetings with health authorities.
Leadership & Collaboration
- Provide mentorship and technical leadership within the Biostatistics team.
- Drive continuous improvement in statistical standards, processes, and tools.
- Collaborate closely with Data Science and Clinical teams to integrate innovative analytical approaches.
Qualifications & Experience:
- 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.