What are the responsibilities and job description for the BIOMETRICS MANAGER position at Luminary Group?
Luminary Group is seeking a talented and experienced Biometrics Manager to join our client. As a Biometrics Manager, you will play a key role in leading and managing the biostatistics and data management functions within the company. You will be responsible for overseeing the design, analysis, and reporting of clinical trial data, ensuring high quality and regulatory compliance.
Responsibilities :
- Lead and manage a team of biostatisticians and data managers, providing guidance, mentorship, and performance evaluations.
- Develop and implement biostatistical and data management strategies for clinical trials across multiple therapeutic areas and phases.
- Oversee the design of clinical trial protocols, including sample size calculations and statistical analysis plans.
- Review and approve clinical trial documentation, including data management plans, data validation plans, and statistical analysis plans.
- Analyze clinical trial data using appropriate statistical methods, ensuring accuracy, consistency, and reliability of results.
- Ensure compliance with regulatory guidelines and industry standards in relation to biostatistics and data management.
- Collaborate with cross-functional teams to integrate biostatistical and data management activities within the clinical development process.
- Provide statistical expertise and support in regulatory interactions and submissions.
- Participate in the development and review of clinical study reports, statistical summary reports, and other regulatory documents.
- Stay up-to-date with the latest advancements in biostatistics and data management methodologies.
- Contribute to departmental initiatives and process improvement projects.
Requirements
