Job description

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.