Job Title: Process CMC Principal Statistician - Vaccines

Location: Waltham, MA

About the Job

In the race for the future of health - The Sanofi mRNA Center of Excellence (CoE)

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

That's why we're looking for bold, optimistic world-changers to join our mRNA Center of Excellence. We're investing €400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

• Represent the mRNA CoE Data and Computational Science team in platform and project technical teams as statistical subject matter expert and drive strategic CMC initiatives within the DS/DP and CMC data strategy
  
• Ensures to high reliability, quality, and optimization by providing an appropriate statistical support to process development, analytical and CMC teams in both GMP and non-GMP studies
  
• Bring statistical expertise and innovation around computational and statistical approaches towards mRNA process development and analytics for projects and cross-platform optimization (use of in silico methods - statistical modelling, simulation, machine learning - for improving bioprocess yields, biophysical stability, and safety profiles of mRNA vaccines and therapeutics)
  
• Bring statistical expertise and leadership in the design of experimental protocols, in the realization and interpretation of the results of statistical analyses and their presentation, automation and standardisation
  
• Design and execute the statistical analysis of complex or critical studies, which might be intended to Health Authorities with writing of statistical study rapports according to the established practices/standards and to participate to the answer to the questions from the Agencies on the registration dossiers and on various regulatory variations/commitments
  
• Lead training of scientists to statistical methods and to the use of validated " end-user " statistical applications
  
• Lead or contribute strategically in global initiatives of harmonization of the practices (within the mRNA CoE and within the partner organizations)
  
• Maintains a well-documented, reusable codebase, and traceable model history
  
• Maintains awareness of latest developments in relevant fields, evaluates and applies as warranted
  
• Generates IP and participates in the drafting of patent filings
  
• Lead preparation and publication of scientific papers and congress reports.
  
• Demonstrate good software engineering practices
  
• Proactively identify, assess, and internalize emerging technologies and methods
  

• Earned PhD in Statistics or other related STEM field required
  
• Recognized leader with at least 5 years' experience in the field of non-clinical statistics applied to biopharmaceutical development and manufacturing is required
  
• Experience collaborating with process and analytical scientists and engineers on the development of biotherapeutics, ideally in the following domains:
  
  • Experimental designs in the context of the development and of the qualification/validation of processes following the QbD approach (selection of experimental design matrices, statistical analysis/modelling of results)
    
  • Statistical modelling & simulation of DS/DP processes
    
  • Statistical process control (univariate & multivariate)
    
  • Validations & transfers of analytical methods (protocols, statistical analysis)
    
  • Statistical analysis of DS and DP characterization and activity tests, stability studies, and comparability studies
    
  • Statistical analysis performed in a GxP environment
    
• Mastery of industrial statistics (descriptive & inferential statistics, statistical process control), design of experiments, multivariate data analysis (PCA, PLS and related methods), statistical modelling and simulation (including Machine Learning) is helpful
  
• Confirmed expertise in process modelling, batch evolution model, and process monitoring
  
• Mastery of statistical and mathematical software (R, Python, JMP, Minitab...) is helpful
  
• Knowledge on CMC regulatory guidelines (ICH Quality, Pharmacopeias) and white papers (ISPE, PDA) and experienced in preparing and presenting proposals and regulatory files to internal and external audiences, including regulatory authorities is preferred
  
• Scientific rigor, organization and project leadership
  
• Good networking skills and fluent interactions with one or more scientific communities, with strong communication and teaching skills is needed
  
• Understanding of vaccine development processes is a plus, as well as familiarity with RNA processes and RNA-centric techniques/methods
  
• Fluent in English (French is a plus)
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• 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.