Head, Nonclinical Biostatistics
Head, Nonclinical Biostatistics
Sanofi
Marcy-l'Etoile, France
About the job
Are you ready to shape the future of vaccines? The race is on to speed up drug discovery and development to find answers for public health. Your skills could be critical in helping our teams accelerate progress. Join our Translational and Nonclinical Biostatistics team in Sanofi Vaccines as the Head of Non-clinical Biostatistics where you will lead a team of experts and deploy state-of-the-art statistical designs and analysis expertise to clinical assays development and CMC analytical science while enjoying lots of opportunities to broaden your experience and hone your skills.
Main responsibilities:
- Accountable for bringing the statistical strategies in the design of experiments and data analyses in the qualification, validation, and optimization of clinical assays across the Sanofi vaccines portfolio. Ensure the science, quality, and compliance throughout life cycle management. Responsible for regulatory statistical responses and medical journal submissions;
- Accountable for deploying CMC vaccines statistical support for analytical methods development, qualification, and validation;
- Lead a team of statistical experts, including recruitment, line management, coaching, mentoring, empowering and performance review for direct reports. Define sourcing strategy and responsible for statistical oversight quality and compliance at CRO;
- Represent Sanofi in related external collaborations (e.g., IMI consortiums, industry standard and white paper) when involving new technologies related to testing and diagnostic assay;
- Advocate sound statistical principles through education of scientists and in applying statistical and modern experimental techniques to improve assay efficiency and to improve existing processes by identifying and reducing source of variabilities.
About you
Experience:
- Proven experience in statistical design and analysis in clinical assays development, optimization and validation from research to life cycle management;
- Proven experience in CMC statistical support for analytical methods development;
- Managerial experience in leading a team to support global functions is desired.
Soft and technical skills:
- Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic development, qualification and validation;
- Statistical technical expertise in CMC analytical science;
- Demonstrated strong project management skills and multitasks under time pressure. Effective communication skills.
Education:
- A Ph.D. or MS in statistics/biostatistics or related discipline.
Languages:
Excellent English writing skills in responding to internal and external reviews. Ability to meet the regulatory standard when document the statistical sections. Knowledge Learning of French is a plus.
© EuroJobsites 2024
