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Sanofi
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Principal Biostatistician-Clinical Statistics

Principal Biostatistician-Clinical Statistics

Sanofi

2 - 6 years

14 - 19 Lacs

hyderabad

Posted:None| Platform:

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Skills Required

sap pharma clinical development clinical trials healthcare wellness manager quality control operations statistics monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job title: Principal Biostatistician
About the job
Our 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. ReadyAs a Principal Biostatistician, you ll 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 people s lives. We re 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. Main 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 Disclosure
Work 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/properties
Ensure 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 initiatives

About you

Experience : Experience in pharmaceutical or related industry experience with clinical trials
Soft and technical skills : Demonstrated interpersonal and communication skills
Good knowledge and good understanding of statistical concepts and techniques
Good knowledge of pharmaceutical clinical development
Able to work in departmental computing environment, can do advanced statistical analyses using SAS, R and other languages.
Education : MS or PhD in Statistics or relevant fields
Languages : Excellent 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 it s through a promotion or lateral move, at home or internationally.
Enjoy a thought
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.

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Sanofi

Pharmaceutical Manufacturing

Paris France

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Principal Biostatistician-Clinical Statistics