Medical Biostatistics and Data Management Location: Marcy, France or US (DUR, STL, SLC) About Us: A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. Our entrepreneurial adventure, begun over a century ago, is driven by an unrelenting commitment to improve public health worldwide . Since 1963, we've been paving the way in the field of in vitro diagnostics and have contributed greatly to improving public health and making the world a healthier place . The solutions that our teams imagine, develop and manufacture are key to enable healthcare professionals and industry players to make confident decisions to improve patient outcome and ensure consumer safety . WHAT WILL YOU BE DOING? Position Summary: The Senior Leader of Global Medical Biostatistics and Data Management is a critical leadership role responsible for overseeing biostatistics and data management functions within the global medical affairs department. This role will ensure robust study design, statistical analysis , data integrity, and effective data management to support a broad range of evidence generation activities intended to demonstrate the value of b io M erieu x products. Key Responsibilities: + Leadership and Strategy: + Build and l ead the biostatistics and data management teams, providing strategic direction and oversight. + Develop and implement strategies to ensure high-quality and innovative study design s , statistical analysis and data management practices across a wide range of evidence generation activities + Collaborate with cross-functional teams to align biostatistics and data management activities with overall business objectives. + Biostatistics: + Oversee the design, analysis, and interpretation of clinical studies and trials. + Ensure appropriate statistical methodologies are applied to study designs and data analysis. + Provide statistical expertise to inform evidence generation activities involving new product development and launch as well as regional evidence needs. + Data Management: + Develop and maintain data management standards, processes, and systems. + Ensure accurate, complete, and timely data collection, processing, and reporting. + Oversee the management of clinical trial databases, including data cleaning and validation. + Regulatory and Compliance: + Ensure compliance with regulatory requirements and industry standards for biostatistics and data management. + Prepare and review statistical sections of manuscripts and other materials generated from evidence generation activities. + Stay current with regulatory guidelines and industry best practices. + Collaboration and Communication: + Collaborate with clinical development, medical affairs, regulatory, and other departments to support product development and post-market activities. + Communicate statistical and data management results to internal and external stakeholders. + Represent the company in interactions with regulatory agencies, key opinion leaders, and scientific communities. + Innovation and Continuous Improvement: + Drive innovation in biostatistical methods and data management practices. + Identify opportunities for process improvements and implement best practices. + Foster a culture of continuous learning and professional development within the team. + And all other duties as assigned WHO ARE YOU? Education, Skills, Experience: + Advanced degree (PhD or MSc) in Biostatistics, Statistics, Data Science, or a related field. + Minimum of 10 years of experience in biostatistics and data management within the pharmaceutical, biotechnology, or IVD industry. + Strong expertise in clinical trial design, statistical analysis . Including Real World Evidence methods . + Proven leadership experience, with the ability to build, manage , and mentor a global team. + In-depth knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, ICH guidelines). + Proven track record of successfully managing and engaging international/cross-cultural teams + Proven track record of having effectively prioritized and led transformational change in a complex, large-scale matrix organizatio n + Excellent written and verbal communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. + Strong problem-solving skills and a proactive approach to addressing challenges. + In depth knowledge of statistical software (e.g., SAS, R) and clinical data management systems (e.g., EDC systems). Travel Requirements: Domestic and international travel required - up to 2 5 %