Job Description

Job title: Principal BiostatisticianLocation: IN / HyderabadAbout the jobOur Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Principal Biostatistician within our Clinical Statistics Team, youll Lead or support one or several early/late phase studies, under minimum supervision of statistical team leader.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Major Responsibilities:Support the clinical study design (including protocol development), the study setup and conduct.Conduct the statistical analyses according to the SAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.Accountable for all assigned statistical deliverables related to one study or specific domain: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables) Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and DisclosureWork with the programming team to provide definitions, documentation and review of derived variables, as well as the quality control plan. Perform and/or coordinate with study programmer the production of statistical analyses.Review and examine statistical data distributions/propertiesEnsure productive collaborations with other functions in the aligned study team and/or safety monitoring team and in communicating with senior leadership.; Promoting teamwork, quality, operational efficiency, and innovation.Represent statistics to participate in scientific or technology working groups or cross function initiativesAbout youExperience: Pharmaceutical or related industry experience with clinical trials.Soft skills: Demonstrated interpersonal and communication skills.Good knowledge and good understanding of statistical concepts and techniquesGood knowledge of pharmaceutical clinical developmentTechnical skills: Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.Education: MS or PhD degree in Statistics or relevant fieldsLanguages: Highly effective communication in English, both oral and 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 its 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.Develop a career of being an influential statisticianGain international clinical trial experiences and communicate with Health Authorities worldwidePursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesnt 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, lets 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 and check out our Diversity Equity and Inclusion actions at !

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