**Job title:** Biostatistician- Vaccines **Location:** Swiftwater, PA **About the Job** The Biostatistician role in Translational and Early Development (TED) Biostatistics team supports Vaccine R&D across preclinical, bioassay technology, CMC, and translational medicine. His/her responsibilities include but not limited to provide statistical support in R&D for pre-clinical studies, clinical bioassay and biomarker research and/or CMC. He/She will work in close collaboration with scientists and clinical project teams to ensure the proper statistical methods are applied in conducting studies and perform statistical activities across the supported functions. Address statistical questions from regulatory agencies. 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 Responsibilities** Acts as the study statistician to support activities under TED scope. For example, be responsible in supporting clinical bioassays in supporting phase 1/2 to phase 3 clinical studies; Clinical assay qualification and validation, and statistical assay performance assessments of various assay platforms. In collaboration with global clinical immunology and clinical project team, address regulatory agency’s questions related to clinical assay platforms and the associated immunological responses, and other relevant statistical matters. His/her responsibility includes but not limited to + Develop the digital mindset and statistical thinking with key stakeholders under his/her responsibility. + Support the digital evolution of the bioassay technology advancement. Provide statistical support throughout this evolution from initial qualification, validation, to assay performance monitoring during clinical study conduct. + Provides statistical input in the assay design stages. Access clinical study samples to estimate the assay performance characteristics. + Generate statistical deliverables and co-author documentations with clients for regulatory submissions. + Provide statistical support of experimental design. Perform statistical analyses, report generation and results interpretation. + Acts as representative in internal initiatives within TED and GBS + Methodological work related to project support. + Develop statistical tools (such as R Shiny) to automate matured/standardized statistical activity. **About You** **Education and Experience:** + Ph.D. in statistics or biostatistics. Pharmaceutical experience is highly desirable. **Knowledge and Skills:** + Ability to apply innovative statistical methods in study design and data analysis. Motivated to conduct research if needed for developing new methods. + Excellent communication and consultation skills to be able to explain statistics to team members who are non-statisticians. + Effective project/study management skills to keep up with timelines and maintain high quality deliverable. + Proficiency and hands-on in statistical computing languages including R, SAS; Familiar with UNIX computing and cloud environments. Experience of parallel computing is a strong plus. + Competency in English both in oral and in written. **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-SP ​ \#LI-SP \#LI-Onsite \#vhd **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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. 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 (https://youtu.be/96EwNjb1TLo) 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 (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)