Senior Biostatistics Lead - Clinical Trials & Submissions

Associate Director, Biostatistics | Hybrid, Greater London Area (UK)

An innovative biotech company is seeking an Associate Director, Biostatistics to provide statistical leadership across clinical development programs. This individual will partner closely with cross-functional teams on study design, statistical analysis, data interpretation, and regulatory submissions.

Key Responsibilities

• Lead statistical strategy and support clinical development programs.
• Contribute to study design, protocol development, and statistical analysis plans.
• Collaborate with Clinical Development, Regulatory, Data Management, Clinical Operations, and Programming teams.
• Provide statistical guidance for ongoing studies and data analyses.
• Support clinical study reports, regulatory submissions, and scientific publications.
• Manage CRO statistical and programming activities.

Qualifications

• PhD in Biostatistics, Statistics, or related field with 7+ years of industry experience, or MS with 10+ years of relevant experience.
• Strong experience supporting clinical trials in a biotech or pharmaceutical environment.
• Proficiency in SAS and knowledge of clinical trial methodology.
• Excellent communication and cross-functional collaboration skills.

Preferred Experience

• Experience supporting late-stage clinical development and regulatory submissions .
• Knowledge of CDISC standards (SDTM, ADaM).
• Experience with R and adaptive trial designs .
• Regulatory agency interaction experience.

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