Principal Statistical Programmer

Posted 21hrs ago

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Job Description

Principal Statistical Programmer developing and validating R programs, SDTM, and ADaM outputs for ICON’s sponsor-dedicated clinical research teams. Supporting regulatory-quality analyses and statistical reporting.

Responsibilities:

  • Develop and validate R programs for statistical analysis and reporting of clinical trial data
  • Lead more than one Statistical Programming team to create, validate, and generate statistical outputs, including listings, tables, figures, and CDISC-compliant SDTM and ADaM datasets, including mapping specifications, of low to moderate complexity
  • Collaborate with biostatisticians to define analysis plans and statistical methods applied to clinical data
  • Perform quality control and validation of statistical outputs, ensuring accuracy, consistency, and regulatory compliance
  • Assist in preparing statistical reports, presentations, and publications for regulatory submissions and clinical study reporting
  • Identify efficiencies in programming practices, automation, and R-based analytical workflows
  • Support development, maintenance, and enhancement of standardized R programming tools, macros, and reporting solutions across studies

Requirements:

  • Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related quantitative field
  • 8+ years' experience in statistical programming within a clinical research, biotechnology, or pharmaceutical environment
  • Strong proficiency in R programming, including the development and validation of clinical trial datasets, analyses, and reporting outputs
  • Good understanding of CDISC standards, including SDTM and ADaM, and their application within clinical trials
  • Familiarity with regulatory requirements and industry guidance related to statistical programming and clinical data reporting
  • Excellent analytical and problem-solving skills, with a keen attention to detail
  • Strong communication skills, with the ability to work collaboratively in a team environment and effectively convey complex information
  • Legal right to work in the country where the role is based

Benefits:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways