Principal Clinical Data & EDC Programmer

ICON plc•Burlington, PE
•Remote

About The Position

ICON is hiring a Principal Clinical Data & EDC Programmer for its Full-Service IOD Clinical Data Science Systems team. This role leads programming for clinical data management systems (CDMS), including dynamic eCRF and edit checks; non-CDMS components such as custom programs, reports, and integrations; analytics solutions; and programs for handling external vendor trial data. The position may be remote or hybrid in Mexico, Colombia, Canada, or the United States. The programmer develops, validates, and maintains clinical-trial programming solutions and provides technical leadership, consultation, review, and mentoring. The role collaborates across functional teams to integrate programming into data management processes, supports study setup and maintenance, and leads cross-study and program-level analytics initiatives and process improvements.

Requirements

  • At least 10 years of experience with EDC programming (Medidata Rave and/or Veeva), data validation outputs, data review/risk management outputs, custom reports, and programs in clinical trials.
  • Proficiency with SQL and/or SAS programming for vendor data imports or DM reconciliation outputs.
  • Experience leading studies, providing training, and mentoring junior programmers.
  • Strong problem-solving and communication skills, with the ability to collaborate in a fast-paced, cross-functional environment.
  • Excellent attention to detail and organizational skills, with a commitment to high-quality results.
  • Bachelor’s degree in a relevant field.

Nice To Haves

  • Experience with bid defense meetings.
  • Experience programming with R and Python.

Responsibilities

  • Develop, validate, and maintain programming solutions for CDMS/EDC systems, data validation outputs, data review and risk management outputs, custom reports, and clinical-trial programs using SAS, R, and/or Python.
  • Develop and maintain programs for external vendor data using SAS, R, and/or SQL.
  • Extract data from CDMS and create data transfer programs.
  • Collaborate with data managers, project managers, biostatisticians, and other positions to integrate programming solutions into the overall data management process.
  • Serve as a primary contact for project-team questions about system programming during study setup and maintenance.
  • Participate in internal and external meetings and provide constructive feedback to peers, team leads, and functional management.
  • Mentor and provide ad hoc guidance, training, and support to other programmers.
  • Support knowledge sharing within the Programmers group through presentations and training materials.
  • Assist with improvements to technical systems and processes in an SME role.
  • Stay current on programming languages and data management tools to improve operational efficiencies.
  • Provide final-level technical review and consultation for complex programming activities.
  • Provide technical leadership for cross-study and program-level analytics initiatives.
  • Lead implementation of innovative analytical techniques, automation strategies, and process improvements.

Benefits

  • Competitive base salary and performance-related incentives.
  • 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.
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