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Sanofi Group Principal Statistician - Research (Non-Clinical) in Cambridge, Massachusetts

Position Overview:

The Non-Clinical Efficacy and Safety (NCES) team, within the Global Biostatistics and Programming Department of Sanofi R&D, contributes to reliability, scientific quality and optimization of Projects/Programs support from "target identification" to "compounds in developmentā€ by providing appropriate non clinical statistical support for efficacy and safety internal or external studies for all R&D entities. NCES main missions are:

  • Bring statistical expertise (Design of experiment, data analysis, interpretation) and take in charge data analyses for internal or external complex or Key studies for decision making.

  • Validate the statistical aspects of Specific Pharmacology Reports written by scientists for the Dossier for all programs.

  • Review key presentations; support answers to Health Authorities on Research or preclinical topics.

  • Contribute to the implementation of end-user statistical applications for routine analyses within labs.

  • Deliver statistical training (methodology and tools).

  • Determine optimal design and sample size in particular for in vivo experiments in the scope of Animal Welfare Committee (AWC).

  • Provide consulting, in particular publication review.

  • Participate to Due diligence on request.

As expert leader, you will be responsible for the methodological and statistical aspects of projects in Research for several therapeutics areas in a WorldWide team of about 10 dedicated statisticians.

Key Responsibilities:

  • Lead statistician on multiple complex projects regarding Non-Clinical Efficacy and Safety (NCES) related Research activities with minimal direction from group head.

  • Accountable for all statistical aspects of NCES plans, studies and submissions activities (when applicable), including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.

  • Mentor people working on the project.

  • Promote teamwork, quality, operational efficiency, and innovation.

  • Create productive work environment.

  • Ensure project team compliance with SOPs and departmental standards.

  • Plan and track project activities, timelines, and resource use.

  • Provide justification for planned resource needs.

  • Seek to optimize resource utilization thru efficient and well-managed resource allocation and across projects or areas.

  • Capacity to respond to unscheduled increase in project workload.

  • Provide technical guidance and mentoring to junior staff.

  • Ensure productive collaborations with other functions in the aligned project team and with other statistics project leaders and in communicating with senior leadership.

  • Represents statistics in regulatory meetings

  • Represent statistics in cross function working groups.

  • Contribute to operation process optimization and provide inputs to statistics standards.

Basic Qualifications:

  • PhD/MS in statistics or related discipline a minimum of 6 years of pharmaceutical experience.

  • Demonstrated strong study management, interpersonal and communication skill.

  • Very good skills in R, SAS ; Rshiny knowledge would be appreciated.

  • Broad knowledge and good understanding of advanced statistical concepts and techniques.

  • Broad knowledge of pharmaceutical development.

  • Broad Research knowledge.

  • Proven experience in preclinical and Research development including submission.

  • Experience in the relevant therapeutic area desired.

  • Ability to represent Sanofi in cross-company activities such a consortiums or professional associations.

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.

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