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PSPSI CRO

Principal Statistician (Pharmacokinetics)(m/w/x)

München
Full-timeOn-siteManagement

Conducting statistical analysis for clinical trials, reviewing study protocols and deliverables. Expert SAS programming and CDISC ADaM standard knowledge required. Mentoring junior staff, client communication focus.

Requirements

  • MSc in Statistics or equivalent
  • Full working proficiency in English
  • Expert knowledge of statistical principles
  • Expert knowledge of SAS programming
  • Expert knowledge of CDISC ADaM standard
  • Expert knowledge of pharmacokinetics principles
  • Expert knowledge of Phoenix WinNonlin and NLME
  • Expert knowledge of relevant regulations
  • Ability to apply advanced statistical techniques
  • Ability to consult with clinical investigators
  • Strong presentation and communication skills

Tasks

  • Serve as a communication link for project teams and clients.
  • Conduct statistical analysis for clinical trials.
  • Develop and review study protocols and analysis plans.
  • Review statistical deliverables like tables and datasets.
  • Conduct training for statisticians and SAS programmers.
  • Prepare for and attend study audits related to statistics.
  • Participate in follow-up for internal and external audits.
  • Provide input to standard operating procedures for Biostatistics.
  • Liaise with data management on statistical data issues.
  • Participate in bid defense and kick-off meetings.
  • Lead teams of SAS programmers and statisticians.

Work Experience

  • approx. 4 - 6 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • SAS
  • Phoenix WinNonlin
  • NLME
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