4h ago

Senior Statistical Programmer / Analyst Consultant

Malvern, PA
senior HybridPharmaceutical / Clinical Research

Description

You will work directly with a sponsor as part of a global CRO, supporting clinical trial programming and submission deliverables. Your work ensures high-quality, compliant statistical outputs for drug development programs.

Requirements

  • Bachelor or Master degree in Computer Science, Mathematics, Engineering, Medical or related discipline
  • Experience in clinical trial statistical programming
  • Knowledge of CDISC standards (SDTM, ADaM)
  • Familiarity with regulatory guidelines (GCP, 21 CFR, ICH)
  • Ability to work independently and establish high-trust client relationships

Responsibilities

  • Program and validate derived datasets, tables, figures, and listings for clinical trials
  • Process external data sources and perform ad hoc exploratory analyses
  • Oversee programming deliverables from CROs
  • Contribute to CDISC-compliant SDTM/ADaM specifications and define packages
  • Ensure programming deliverables are on time and of high quality
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