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 and development 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 helping our 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. #GD-SA #LI-SA #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn?t happen without people ? people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let?s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube

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