RBW Consulting
Associate Director Biostatistics
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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.
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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.
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Preferred Experience
- Experience supporting late-stage clinical development and regulatory submissions.
- Lead statistician experience.
- Knowledge of CDISC standards (SDTM, ADaM).
- Experience with R and adaptive trial designs.
- Regulatory agency interaction experience.
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