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A Range of Possibilities

Statistical Safety Science Statistician - all genders

date posted 08/28/2022
contract type Full time
job id R2648643
location Bridgewater, NJ;Chilly-Mazarin;

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.  

The position is open for Germany, France and the USA.

Major Duties and Responsibilities

  • Lead safety signal detection , validation and charaterisation for one or several project 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.
  • 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 of  quality 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 and provide inputs to statistics standards.

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 communication skill
  • Broad knowledge and good understanding of advanced statistical concepts and techniques
  • Broad knowledge of pharmaceutical clinical development
  • Broad experience in clinical development or post-marketing activities such a submissions, interactions with regulatory agencies or other external stakeholders
  • Experience safety signal detection  desired
  • Ability to represent Sanofi in cross-company activities such a consortiums or professional associations

Our offer:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g., company pension plans, health management).
  • An individual and well-structured introduction and training of new employees.
  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
  • As a globally successful and constantly growing company, Sanofi provides international career paths as well.

#LI-GS

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.

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