Job title: Director Non-clinical Biostatistics - Vaccines

• Location: Swiftwater, PA or Waltham, MA (must have ability to work onsite 2-3 days per week per Hybrid working policy)

Position Overview

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 Director 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.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

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
  • Broad knowledge and good understanding of statistical techniques and regulatory requirements in clinical assay and diagnostic development, qualification and validation
  • Demonstrated strong project management skills and multitasks under time pressure. Effective communication skills.
  • Managerial experience in leading a team to support global functions is desired

• Education:
  • A Ph.D. or MS in statistics/biostatistics or related discipline with at least 8+ years of pharmaceutical experience in related areas

• Languages:
  • Excellent English writing skills in responding to internal and external reviews. Ability to meet the regulatory standard when documenting the statistical sections
  • Working knowledge of French is a plus

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Develop and deploy your passion for statistical sciences into concrete outcomes, positively impacting society
• Discover a new environment, as part of a team deploying end-to-end statistical sciences across the R&D value chain, giving opportunity growing your talent
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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