Senior Director of Biometrics

July 24

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Luminary Group

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Description

• 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.