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.
