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PSPSI CRO

Principal Statistician(m/w/x)

München
Full-timeOn-siteManagement

Statistical analysis for clinical trials, developing study protocols, and training statisticians at a global CRO. Expert knowledge of SAS programming and CDISC ADaM standard required. Mentoring opportunities for junior statisticians.

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 adaptive designs
  • Expert knowledge of sample size calculation
  • 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/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
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