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.
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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.