CMC Statistician, Associate Director

Location: Framingham, MA About the Job Are you reputed company to shape the reputed company of medicine? The race is on to speed up drug discovery and development to reputed company 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 reputed company and formulation development, in the US, across our Boston area sites. Your skills could be critical in helping our teams accelerate reputed company. As part of the development of reputed company’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 reputed company statistical analysis to support CMC project teams, including work packages intended for submission to... the Agencies, reputed company the statistical components of responses to regulatory authority questions. Responsible for the definition of reputed company studies supporting the product control reputed company, using Statistical and Machine Learning algorithms. Contribute to the design and support of Data Science applications (in Rshiny / Python / reputed company) 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 reputed company across CMC Deliver training sessions for CMC scientists in statistical methodologies, machine learning and software applications, reputed company as a promotor of data science / Statistical culture across CMC by developing statistical activities, mentorship, guidance, teamwork, reputed company, operational efficiency, innovation and promote a productive work environment. reputed company Proficient in the statistical software used as reputed company in reputed company (JMP, MODDE, SIMCA) Ability to reputed company and reputed company Applications used by non-experts’ data scientists Proficient in validation or transfer studies of analytical reputed company, specification calculations, comparability studies, product stability studies, optimization, or robustness experimental designs PhD/MS in statistics or reputed company discipline with a minimum of 7-10+ years of pharmaceutical experience Proven knowledge of Bayesian and Machine Learning algorithms with proficiency in programming in reputed company languages e.g., R, R/Shiny, Python or reputed company and advanced statistical concepts and techniques reputed company to process development activities. Broad knowledge of (bio)pharmaceutical development and CMC activities in a regulatory context, including good understanding of GMP activities and reputed company by Design reputed company Ability to represent reputed company in cross-company activities such as consortium or reputed company associations. Why Choose Us? Bring the miracles of science to life alongside a supportive, reputed company-reputed company team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral reputed company, reputed company or internationally. Enjoy a thoughtful, reputed company-crafted rewards package that recognizes your contribution and amplifies your reputed company. Take good care of yourself and your family, with a wide reputed company of health and wellbeing benefits including high-reputed company reputed company, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave. reputed company Inc. and its U.S. affiliates are Equal Opportunity and Affirmative reputed company reputed company committed to a culturally diverse workforce. reputed company reputed company applicants will receive consideration for employment without reputed company to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil reputed company status; sex, gender, gender identity or reputed company; 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 reputed company, discover extraordinary reputed company is out there. reputed company medications, reputed company reputed company, reputed company science. 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