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Principal Statistical Programmer

ICON Strategic Solutions

New
Senior 🇬🇧 English
CDISC SDTM ADaM

Job description

About the role

ICON Strategic Solutions is seeking a Principal Statistical Programmer to join its sponsor-dedicated team. The role involves analysing clinical trial data and supporting the statistical analysis process so that high-quality results are delivered. It includes developing and validating statistical programs in R, working with biostatisticians and ensuring compliance with regulatory standards.

Key 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 for 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.
  • Contribute to process improvements through efficiencies in programming practices, automation and R-based analytical workflows.
  • Support the development, maintenance and enhancement of standardised R programming tools, macros and reporting solutions across studies.

Required profile

  • Bachelor's or Master's degree in Statistics, Mathematics, Computer Science, Life Sciences or a related quantitative field.
  • 8+ years of experience in statistical programming within clinical research, biotechnology or pharmaceutical environments.
  • Strong exposure to leading programming activities for clinical studies.
  • Excellent analytical and problem-solving skills, with a keen attention to detail.
  • Strong communication skills and ability to work collaboratively in a team.

Required skills

  • Strong proficiency in R programming, including development and validation of clinical trial datasets, analyses and reporting outputs.
  • Good understanding of CDISC standards, including SDTM and ADaM.
  • Familiarity with regulatory requirements and industry guidance on statistical programming and clinical data reporting.

What we offer

  • A competitive salary.
  • Annual leave entitlements.
  • Health insurance options for you and your family.
  • Retirement planning offerings.
  • Global Employee Assistance Programme (LifeWorks).
  • Life assurance.
  • Optional country-specific benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships and subsidised travel passes.

Questions fréquentes

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Published 6 hours ago

Expires 1 month from now

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ICON Strategic Solutions