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Job Description
Biometrics Manager sought to lead biostatistics and data management functions, overseeing clinical trial data design, analysis, and reporting, ensuring high quality and regulatory compliance.
Luminary Group is seeking a talented and experienced Biometrics Manager to lead and manage the biostatistics and data management functions within the company.
As a Biometrics Manager, you will play a key role in leading and managing the biostatistics and data management functions within the company.
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 Ph.D. 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.