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Safety Expert Statistician

At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

At Sanofi, we chase the miracles of science to improve people's lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Job Summary

Provide leadership and guidance as the lead statistician dedicated to safety on one or more safety monitoring team(s), accountable for all methodological and statistical aspects for safety data analyses around pooled clinical trial data of project(s). Act as statistical consultant within company for safety analyses, also on individual trial level.

Major Duties and Responsibilities

  • Lead safety signal detection, validation, charaterisation and reporting for several projects with minimal direction from group head, direct statistical support and provide statistical scientific leadership for clinical trial safety data within a project. Accountable for statistical aspects for safety analysis, including quality, relevance to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity.
  • Accountable for all safety statistical deliverables for complex projects
  • Promote teamwork, quality, operational efficiency, and innovation. Ensure safety monitoring team compliance with SOPs and departmental standards.
  • Plan and track project activities related to safety, 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 workload.
  • Lead discussion around definition and harmonization ofquality standards also on individual trial level within and across therapeutic areas.
  • Provide technical guidance and mentoring to junior staff.
  • Ensure productive collaborations with other functions in the safety monitoring team and with other statistics project leaders and in communicating with senior leadership.
  • Represent statistics to participate (and lead if applicable) in scientific or technology working groups or cross function initiatives. Contribute to operation process optimization. Develop, promote state-of-the-art methodology and standards for safety analyses.

Required Education/Experience:

  • PhD/MS in statistics or related discipline with at least 6 years of pharmaceutical experience Knowledge of epidemiology methods and concepts in safety context
  • Demonstrated strong project/study management, interpersonal and communicationskills
  • Broad knowledge and good understanding of advanced statistical concepts and techniques, including bayesian methodology
  • Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders
  • Experience safety signal detectiondesired
  • Ability to represent Sanofi in cross-company activities such a consortiums or professional associations
  • Ability and mindset to embrace change, innovate and continuously improve practice

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.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

#LI-Hybrid

Diversity und Inklusion sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.

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Safety Expert Statistician

Cambridge, Massachusetts
Vollzeit

Veröffentlicht am 02.05.2024

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