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Job description
Are you ready to shape the future of medicine? The race is on to speed up drug discovery anddevelopment to find answers for patients and their families. The CMC-Biologics Statistics team is seeking an expert data scientist / Statistician to support the CMC activities for process, analytical methods and formulation development, in the US, across our Boston area sites. Your skills could be critical in helpingour teams accelerate progress.
As part of the development of Sanofi’s pharmaceutical products, the R&D Data Sciences department and more specifically the Statistics department for the Chemical Manufacturing Control (CMC) of biological products (CMC-Biologics Statistics), is responsible for contributing to statistical support, modeling, digitalization, decision-making and filing of new product registration files.
Main Responsibilities
Provide statistical analysis to support CMC project teams, including work packages intended for submission to the Agencies
Provide the statistical components of responses to regulatory authority questions
Responsible for the definition of complex studies supporting the product control strategy, using Statistical and Machine Learning algorithms
Contribute to the design and support of Data Science applications (in Rshiny / Python / SAS) to be used by CMC scientists
Ensure effective collaborations with other statistical leaders, scientific project leaders and senior leadership to advance the definition of robust control strategy across CMC
Deliver training sessions for CMC scientists in statistical methodologies, machine learning and software applications
Act as a promotor of data science / Statistical culture across CMC by developing statistical activities, mentorship, guidance, teamwork, quality, operational efficiency, innovation and promote a productive work environment
About You
Proficient in the statistical software used as standard in Sanofi (JMP, MODDE, SIMCA)
Ability to develop and deploy Applications used by non-experts’ data scientists
Proficient in validation or transfer studies of analytical methods, specification calculations, comparability studies, product stability studies, optimization, or robustness experimental designs
PhD/MS in statistics or related discipline with a minimum of 7-10+ years of pharmaceutical experience
Proven knowledge of Bayesian and Machine Learning algorithms with proficiency in programming in standard languages e.g., R, R/Shiny, Python or SAS and advanced statistical concepts and techniques applied to process development activities
Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding of GMP activities and Quality by Design framework
Ability to represent Sanofi in cross-company activities such as consortium or professional associations
Why Choose Us?
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
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Aff
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Worksite address
framingham, MA, 01704, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.