Luminary Group
Luminary Group is a global consultancy specializing in life sciences. The company offers executive search, staffing, and consulting services across various fields including pharmacovigilance, regulatory affairs outsourcing, market access, and product development. Additionally, Luminary Group provides expertise in biotechnology, medical devices, and clinical research organization (CRO) sectors, focusing on areas such as predictive medicine, machine learning, genomics, and genomics proteomics. Their services extend to enterprise SaaS solutions and real-world evidence, supporting prestigious clients around the world.
Senior Director of Biometrics
July 24, 2024
Luminary Group
Luminary Group is a global consultancy specializing in life sciences. The company offers executive search, staffing, and consulting services across various fields including pharmacovigilance, regulatory affairs outsourcing, market access, and product development. Additionally, Luminary Group provides expertise in biotechnology, medical devices, and clinical research organization (CRO) sectors, focusing on areas such as predictive medicine, machine learning, genomics, and genomics proteomics. Their services extend to enterprise SaaS solutions and real-world evidence, supporting prestigious clients around the world.
📋 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.
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