Process CMC Senior Principal Statistician - Vaccines

Job Title: Process CMC Senior Principal Statistician- Vaccines

Location: Waltham, MA

About the Job

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.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

As an experienced mRNA Process CMC Senior Principal Statistician, you will lead and coordinate the team providing statistical support to the mRNA CoE scientists / SMEs (Subject Matter Experts)/engineers for process, formulation and analytics of mRNA Drug Substance (DS) and Drug Product (DP); as part of the Data and Computational Science team in the mRNA CoE. This team brings end to end data integration and advanced analytics (pre-clinical, biomarkers, process development, CMC, clinical) in the mRNA CoE. Deploying and exploiting digital solutions (AI/machine learning, data, analytics) to integrate the full data value chain, extracting actionable information for a move to a full data driven strategy and decision-making process, to increase probability of success and to accelerate mRNA vaccines and therapeutics development and launch.

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 Responsibilties:

• Represent the mRNA CoE Data and Computational Science team in platform and project technical teams as statistical CMC lead and subject matter expert and develop and drive strategic CMC initiatives within the DS/DP and CMC data strategy

• Ensures high reliability, quality, and optimisation by providing an appropriate statistical support and guidance to process development, analytical and CMC teams in both GMP and non-GMP studies

• Bring broad 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 broad 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 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

About You

• Earned PhD in Statistics or other related STEM field required

• Recognized leader with at least 7 years’ experience in the field of non-clinical statistics applied to biopharmaceutical development and manufacturing is required

• Experienc