Senior Biostatistician

JR United Kingdom; Southampton; On-site; GBP 70,000 - 120,000; Full time

Job summary

A leading clinical trial organization is seeking a highly experienced Lead Biostatistician for a long-term contract position. The role involves providing expert statistical leadership across multiple clinical trial projects, ensuring high-quality results, and collaborating with both technical and non-technical teams.

Qualifications

• Extensive experience as a Lead Biostatistician in pharma/biotech.
• Strong understanding of statistical methodologies and ICH guidelines.
• Experience with Phase II and Phase III clinical trials.

Responsibilities

• Develop protocols and provide input on trial design.
• Lead statistical analysis and oversee biostatistics deliverables.
• Ensure statistical integrity of study reports and collaborate with stakeholders.

Skills

Statistical methodologies

Clinical trial design

Regulatory requirements

Excellent communication skills

Collaboration skills

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