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Clinical Programmer (SDTM SME)

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Primary Location: Durham, North Carolina, United States Full time R1298955

Job description

Job Summary

Clinical Solutions Group, an IQVIA business, is seeking an SDTM SME for a remote position. The successful candidate will have strong knowledge on SDTM and ADaM specifications. Incumbent must have the ability to follow processes, but not blindly accept policy, while working on a team with strong ADaM experience.

Primary Job responsibilities

  • Drives change management by conceiving and operationalizing innovation and facilitating adoption across teams.
  • Mapping data from Medidata or InForm into SDTM
  • Designs, deploys, and maintains various cross-functional solutions, business processes, and associated technologies such as statistical computing environment, metadata repository, output delivery depot and standard macro library.
  • Identify and provide feedback on business processes areas of improvement
  • Delivers optimization of end-to-end business processes that enable quality and efficiency such as process maps, SOPs, and work instructions.
  • Engages with multi-disciplinary experts to influence, elicit, analyze, and document business requirements and translate into technology functional requirements.
  • Leverages project management tools and software development methodologies to manage resources, mitigate risk and deliver on commitments.
  • Evaluate and recommend upcoming industry trends, best practices, cutting-edge tools and novel programming approaches that leverage machine learning, simulation, robotic automation, metadata driven processes, artificial intelligence and natural language processing.
  • Ensures adherence to global and local agency regulations, good clinical practices (GCP), ICH guidelines, SOP’s, and functional quality standards.
  • Other duties as assigned

Required Skills

  • Bachelor of Science in computer science, data science, statistics, or a related field with 7+ years of relevant experience. Master’s degree preferred.
  • Strong experience in mapping laboratory data, ECG, Pharmacokinetic/Pharmacodynamic data, ePRO (Electronic Patient Reported Outcomes), eDiary, Device Data, or other non-EDC data
  • Ability to effectively communicate complex analytical and technical concepts with clarity, both written and oral.
  • Fundamental knowledge of SDTM and ADaM specifications
  • Intermediate-level proficiency in SAS, R, python, shell scripting or other programming languages. Intermediate-level knowledge of statistical and data mining techniques.
  • Demonstrated problem-solving, analytical, and multitasking skills.
  • Programming certifications and proficiency in multiple programming languages desirable.
  • Familiarity with various programming paradigms and IT system architectures desirable.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status.

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