Senior Manager, Biostatistics

Discover International is looking for a Senior Manager, Biostatistics

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Job 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.
Stay current with emerging statistical guidance and industry best practices.

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.

Full-time jobs | Secondary School

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