Senior Biostatistician
Posted 2 weeks ago by Vine Resources
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: The role of Lead Biostatistician involves providing expert statistical leadership for clinical trial projects, focusing on study design, protocol development, and statistical analysis. The position requires collaboration with various stakeholders to ensure the integrity and quality of statistical deliverables. This is a long-term contract opportunity within the pharmaceutical/biotechnology industry, emphasizing the importance of communication and innovative statistical methods.
Key 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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