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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 clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com