Job Information
BioFire Diagnostics, LLC. Sr Director, Biostatistics & Data Mgmt in Salt Lake City, Utah
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 %