Non Clinical Efficacy and Safety Statistician Expert Leader (m/f/d)

  • Sanofi
  • Frankfurt am Main, Germany
  • 04/10/2021
Full time Data Science Data Engineering Data Analytics Big Data Data Management Statistics

Job Description

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 development” 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.

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.

Requirements

  • 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

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-GSA

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.