Biostatistician

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, realworld evidence (RWE) initiatives, metaanalyses, 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 crossfunctional scientific discussions. This position requires close collaboration with crossfunctional 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 highquality TFLs and technical reports.
• Conduct metaanalyses, 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 metaanalyses/evidence synthesis
• Experience in Medical Affairs, postmarketing 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 bioMerieux 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%

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BioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMerieux's or its affiliates' application process by contacting us via telephone at (385) 770-1132, by email at [emailprotected], or by dialing 711 for access to Telecommunications Relay Services (TRS).