Senior Biostatistician

JR United Kingdom; Belfast; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Lead Biostatistician for a long-term contract role. This position will provide expert statistical leadership on clinical trial projects, focusing on design, analysis, and regulatory compliance. Candidates should possess extensive experience and excellent communication skills to engage with both technical and non-technical stakeholders.

Qualifications

• Extensive experience as a Lead Biostatistician in the pharmaceutical/biotech industry.
• Strong understanding of statistical methodologies and ICH guidelines.
• Proven ability to lead clinical trial statistical aspects.

Responsibilities

• Develop and provide input on trial design, protocol development.
• Lead statistical analysis and oversee biostatistics deliverables.
• Collaborate with stakeholders and present statistical concepts.

Skills

Statistical methodologies

Clinical trial design

Regulatory requirements

Communication

Collaboration

Job description

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We are seeking a highly experienced Lead Biostatistician for a long-term contract engagement to provide expert statistical leadership on clinical trial projects.

You'll be supporting study design, protocol development, and all other statistical aspects of clinical trials.

Responsibilities:

• 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.
• Present statistical concepts to both technical and non-technical audiences.

Experience:

• Extensive experience as a Lead Biostatistician within the pharmaceutical/biotechnology industry.
• Strong understanding of statistical methodologies, clinical trial design, and regulatory requirements (e.g., ICH guidelines).
• Proven ability to lead statistical aspects of clinical trials from planning to reporting.
• Excellent communication and collaboration skills.
• Experience of Phase II and Phase III is essential

This is a long-term contract opportunity. Please apply if interested