Clinical Trial à United States

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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