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Senior regulatory

Newport (Isle of Wight)
Vine Resources
Posted: 12h ago
Offer description

We are seeking a highly experienced Lead Biostatistician for a long-term contract engagement to provide expert statistical leadership on clinical trial projects.
Develop protocols, providing input on trial design and reporting's statistical, scientific, and operational aspects.
Implement novel statistical methods and innovative trial designs in collaboration with Project Statisticians.
Lead statistical analysis and reporting for multiple studies, including statistical deliverable meetings and exploratory analyses.
Oversee biostatistics deliverables for assigned trials, ensuring timely and high-quality results.
Collaborate with internal and external stakeholders, explaining statistical concepts to non-statisticians.
Ensure statistical integrity of study reports, adhering to internal standards and regulatory guidelines.
Support statistical programming implementation and QC.
Extensive experience as a Lead Biostatistician within the pharmaceutical/biotechnology industry.
Strong understanding of statistical methodologies, clinical trial design, and regulatory requirements (e.g., Proven ability to lead statistical aspects of clinical trials from planning to reporting.
This is a long-term contract opportunity.

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