Aufgaben

  • Implement and maintain programs for analyzing and reporting clinical trial data
  • Review trial documentation and provide feedback from a statistical programming perspective
  • Define and design project and trial analysis datasets and metadata, including complex derivations and mappings
  • Develop and generate Tables, Listings, and Figures (TLFs) for trial reports and statistical analyse
  • Perform quality control (QC) activities in compliance with company SOPs and industry standards
  • Collaborate with trial programmers, statisticians, and clinical trial teams to ensure accurate data presentation and deliverables
  • Maintain up-to-date documentation and ensure proper filing in the eTMF system
  • Provide technical advice and support to colleagues and contribute to department-wide initiatives
  • Support the implementation of computerized systems and tools to facilitate trial data analysis and workflow
  • Ensure compliance with ICH-GCP regulations and company SOPs

Qualifikationen

  • University degree in mathematics, informatics, or a scientific discipline (or equivalent)
  • Advanced proficiency in SAS programming and statistical analyses in clinical trials
  • Strong knowledge of CDISC standards, especially SDTM and ADaM
  • Basic knowledge of R and familiarity with other programming languages is an asset
  • Minimum of 4 years of experience in statistical programming, including 3 years within a pharmaceutical company or CRO
  • In-depth understanding of ICH-GCP regulations and clinical research requirements
  • Strong problem-solving skills and the ability to analyze complex issues logically
  • Excellent communication skills in English; knowledge of other languages is a plus
  • Proven ability to work independently while contributing to team goals