Job Description

The Biostatistics and Data Management team plays a central role in ensuring high-quality, reliable data supports evidence generation, regulatory submissions, and post-market activities. We are seeking a highly skilled and motivated Biostatistician to provide statistical leadership and analytical expertise to support global evidence generation. The role ensures appropriate statistical design, robust analysis, and clear interpretation of Medical Affairs studies, real‑world evidence (RWE) initiatives, meta‑analyses, and investigator initiated research. The Biostatistician serves as a statistical partner for Global Medical Affairs evidence generation activities, including support for study proposal evaluation, protocol development, statistical analysis plans, advanced data analytics, publications, and cross‑functional scientific discussions. This position requires close collaboration with cross‑functional global and U.S. Medical Affairs teams, scientific experts, and external investigators. Strong communication and cross-functional partnership are essential.

Primary Duties

• Review study proposals for statistical rigor, feasibility, and alignment with scientific objectives.
• Develop statistical design elements including endpoints, hypotheses, sample size justification, and analysis strategies.
• Create and/or review statistical analysis plans (SAPs) for clinical, observational, and real-world studies.
• Perform statistical analyses using SAS and/or R, generating high‑quality TFLs and technical reports.
• Conduct meta‑analyses, pooled analyses, and evidence synthesis using established and innovative methodologies.
• Provide statistical input to protocols, charters, and scientific documents.
• Partner with Medical Evidence Strategy, Evidence Generation and Medical Education teams to deliver coherent evidence packages.
• Support development of abstracts, posters, oral presentations, and manuscripts through statistical interpretation and review.
• Ensure statistical quality and compliance with internal standards, GCP, and relevant regulatory/statistical guidance.
• Advise on appropriate data sources and methodological considerations for RWE projects.
• Support external research collaborations and provide statistical oversight to CROs or academic partners.
• Contribute to development/improvement of internal statistical templates, standards, and best practices.
• Communicate complex statistical concepts to non-statistical audiences clearly and effectively.
• Provide informal mentoring or technical support to junior team members as needed.
• Perform all work in compliance with company quality procedures and standards.
• Perform other duties as assigned.

Qualifications
Required Education, Training and Experience

• PhD in Biostatistics, Statistics, or related field
• 5+ years of professional related experience with the following:
  • Experience with statistical design and analysis of clinical or observational studies
  • Proficiency in SAS and/or R
  • Experience contributing to protocols/SAPs and producing TFLs

Preferred Education, Training and Experience

• Experience in statistical methods in clinical research studies
• Experience performing meta‑analyses/evidence synthesis
• Experience in Medical Affairs, post‑marketing research, or real-world evidence preferred
• Publication experience in clinical/medical journals
• Experience collaborating with cross-functional scientific teams

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Effective Presentation Skills - including the ability to present technical data
• Analyze data and make decisions/recommendations, using data to guide decision-making and provide suggestions for improvement.
• Thriving in a fast-paced environment by managing tasks, multitasking, and adapting quickly to maintain productivity.
• Planning objectives and strategies to achieve them within a set timeline
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel
  • Advanced: demonstrates deep knowledge; manages complex tasks and integrates multiple tools independently
• Advanced proficiency in SAS and/or R
• Experience with clinical, observational, registry, and claims/EMR datasets
• Strong communication skills to partner with Clinical Research Scientists, Market Access and external investigators

Domestic travel required: 5%
International travel required: 5%
Total travel required: 10%

The estimated salary range for this role is between $130,000 and $157,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer. In addition, bioMérieux offers a competitive Total Rewards package that may include: · A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options · Company-Provided Life and Accidental Death Insurance · Short and Long-Term Disability Insurance · Retirement Plan including a generous non-discretionary employer contribution and employer match. · Adoption Assistance · Wellness Programs · Employee Assistance Program · Commuter Benefits · Various voluntary benefit offerings · Discount programs · Parental leaves #LI-US