CMC Statistician, Associate Director

Location: Framingham, MA

About the Job

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 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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