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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 crossfunctional 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 endtoend business processes that enable quality and efficiency such as process maps SOPs and work instructions.
Engages with multidisciplinary 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 cuttingedge 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 SOPs 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. Masters degree preferred.
Strong experience in mapping laboratory data ECG Pharmacokinetic/Pharmacodynamic data ePRO (Electronic Patient Reported Outcomes) eDiary Device Data or other nonEDC data
Ability to effectively communicate complex analytical and technical concepts with clarity both written and oral.
Fundamental knowledge of SDTM and ADaM specifications
Intermediatelevel proficiency in SAS R python shell scripting or other programming languages. Intermediatelevel knowledge of statistical and data mining techniques.
Demonstrated problemsolving 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
Required Experience:
Senior IC
Full-Time