Luminary Group is seeking a talented and experienced Senior Biometrics Director to join our client. As a Biometrics leader, 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
- Master's or PhD in biostatistics, statistics, or a related field.
- Minimum of 7 years of experience in biostatistics and data management in the pharmaceutical or biotechnology industry.
- Prior experience in a leadership or management role.
- Strong knowledge of statistical methodologies used in clinical trials, including sample size calculation, randomization, and statistical analysis.
- Experience with statistical software such as SAS or R.
- Experience with data management tools and clinical data standards.
- Knowledge of regulatory guidelines and requirements related to biostatistics and data management.
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
- Strong problem-solving and decision-making abilities.
- A high level of attention to detail and accuracy.
- Publication record in peer-reviewed journals is desirable.
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