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PSI CRO
4mo ago

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

München
Full-timeOn-siteManagement

Description

You manage statistical analysis and deliverables for clinical trials, ensuring effective communication and training while leading teams and participating in audits and meetings.

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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

Education

Master's degree

Work Experience

approx. 4 - 6 years

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.

Tools & Technologies

SASPhoenix WinNonlinNLME

Languages

English – Business Fluent

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