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IQIQVIA

PK/PD Statistical Programmer(m/w/x)

Frankfurt am Main
Full-timeWith Home OfficeSenior

Programming and validating NONMEM-ready datasets for clinical trial data in drug development. 6+ years industry experience in clinical data analysis and expert R proficiency required. Work in a global clinical research environment.

Requirements

  • Bachelor's or Master's degree in health, science, IT, mathematics, or related field
  • Minimum 6 years industry experience in clinical data analysis, statistical programming, or pharmacometrics support
  • Expert-level proficiency in R
  • Hands-on experience creating NONMEM datasets
  • Strong understanding of SDTM, ADaM, and controlled terminology
  • Applied knowledge of PK/PD principles and clinical trial concepts
  • High attention to detail, strong analytical, documentation, and communication skills
  • Ability to work independently and collaboratively
  • Experience building/enhancing NONMEM dataset workflows
  • Experience with R package testing, validation frameworks, or reproducible programming
  • Familiarity with pharmacometrics workflows

Tasks

  • Program, validate, and deliver NONMEM-ready PK/PD datasets.
  • Create high-quality PK/PD datasets for pre-lock and post-lock clinical data.
  • Execute complex programming tasks independently.
  • Critically review data.
  • Identify data inconsistencies and gaps.
  • Propose solutions for dataset quality and programming efficiency.
  • Perform quality control on internal and external NONMEM datasets.
  • Assist in preparing deliverables for regulatory submissions.
  • Perform QC on customized R packages.
  • Enhance or build automated test suites.
  • Collaborate with cross-functional teams to resolve data issues.
  • Ensure alignment with cross-functional teams.
  • Adhere to SOPs, working instructions, and regulatory standards.
  • Maintain inspection readiness.
  • Drive PM standardization for dataset creation and QC.

Work Experience

  • 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • R
  • NONMEM
  • SDTM
  • ADaM
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