Head of Biometrics

Luminary Group, a leader in the pharmaceutical industry, is seeking a talented and experienced Head of Biometrics to join our client in France. As the Head of Biometrics, you will play a key role in leading and overseeing the biostatistics and data management functions for our operations in France. You will be responsible for providing strategic direction, managing a team of biostatisticians and data managers, and ensuring the successful execution of clinical trials.

Responsibilities:

• Lead, manage, and develop a team of biostatisticians and data managers, providing guidance, mentorship, and performance evaluations.
• Develop and implement biostatistical and data management strategies for clinical trials conducted in France.
• Oversee the design, analysis, and reporting of clinical trial data, ensuring data integrity, accuracy, and regulatory compliance.
• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, and Regulatory Affairs, to provide statistical expertise in study design, protocol development, and data analysis.
• Review and approve clinical trial documentation, including clinical study protocols, statistical analysis plans, and regulatory submissions.
• Analyze clinical trial data using appropriate statistical methods and software, ensuring high quality and reliable results.
• Provide statistical insights and interpretation of trial results, contributing to clinical study reports and publications.
• Stay up-to-date with the latest advancements in biostatistics, regulatory guidelines, and industry best practices.
• Ensure compliance with regulatory requirements, data standards, and quality assurance processes.
• Contribute to process improvement initiatives and the development of departmental policies and procedures.

Requirements

• Advanced degree (PhD or Master's) in biostatistics, statistics, or a related field.
• Minimum of 10 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.
• Proficiency in statistical software such as SAS or R.
• Experience with data management tools and clinical data standards.
• Strong understanding of regulatory guidelines and requirements related to biostatistics and data management in France.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and external stakeholders.
• Experience working in the French regulatory environment and familiarity with French healthcare regulations is preferred.
• Strong problem-solving and decision-making abilities.
• A high level of attention to detail and accuracy.
• Publication record in peer-reviewed journals is desirable.