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