CMC Statistician (m/f/d).

Job ID: 11353

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Discipline
Quality/Production
Type of employment
Project Consulting
Company
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
Responsibilities

Under close supervision from Statistical Project Leader and/or Group Head, contribute to the reliability, scientific quality and optimization of project support providing statistical support to CMC customers locally on her/his site and, as needed, on a remote manner to CMC customers from distant sites (R&D and Industrial Affairs):

  • Be responsible for the statistical aspects of designing and analyzing complex or critical studies, generally intended to Health Authorities with writing of statistical study rapports by keeping internal and external practices/standards
  • Perform designs of experiments building and analysis (Determine optimal design and sample size for formulation and process optimization)
  • Perform data analyses
  • Act as the Stat CMC statistics contact and local interface of the CMC Statistics group to related functions and customers
  • Bring statistical expertise and provide consulting for high quality experimental designs, data analysis and interpretation of results
  • Promote statistical thinking and culture within laboratories
  • Deliver training sessions in statistics for the scientists (methodology and tools). Support and train customers on validated statistical “end-user” applications
  • Participate to internal technical working groups and networks of statisticians
  • Contribute to the development and support of statistical end-user tools
Requirements
  • PhD/MS in statistics or related discipline; with minimum of 2 years of pharmaceutical experience
  • Preferably good knowledge of pharmaceutical research and development process
  • GMP knowledge
  • Good knowledge and good understanding of key statistical concepts and techniques in CMC area
  • Able to work in departmental computing environment, do advanced statistical analyses using SAS and possibly other languages (R, …)
Region
Mitte