Sr Director, Biostatistics and Data Mgmt

Location: Salt Lake City, UT, United States Position Type: Unfixed Term Job Function: Medical Affairs

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A world leader in the field of in vitro diagnostics for more than 60 years, bioMerieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 6,200 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada. Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Description

Medical Biostatistics and Data Management

Location:Marcy, France or US (DUR, STL, SLC)

About Us:A family-owned company, bioMerieux has grown to become a world leader in the field ofin vitrodiagnostics. Our entrepreneurial adventure, begun over a century ago, is driven by an unrelenting commitment toimprove public health worldwide.

Since 1963, we've beenpaving the way in the field ofin vitro diagnosticsand have contributed greatly toimproving public healthandmaking the world a healthier place.

The solutions that our teams imagine, develop and manufacture arekey to enable healthcare professionals and industry players to make confident decisionstoimprove 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 bioMerieux products. Key Responsibilities: * Leadership and Strategy: * Build and lead the biostatistics and data management teams, providing strategic direction and oversight. * Develop and implement strategies to ensure high-quality and innovative study designs, 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 e xternal stakeholders. * Represent the company in interactions with regulatory agencies, key opinion... For full info follow application link.