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North Carolina 540, Raleigh, NC, USA
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>> Seeking a highly experienced Senior Statistical Programmer / Clinical Data Architect with 15+ years of expertise in clinical data programming, CDISC standards, and cloud-based analytics platforms.
>> Lead end-to-end clinical data workflows, regulatory submissions, and modern data platform transformations in GxP-regulated environments
. >> Strong domain expertise in SDTM, ADaM, regulatory submissions, and SAS/Python/R programming.
>> Experience in cloud platforms (AWS/Azure) and clinical data modernization initiatives.
Requirements:
>> Bachelor’s or Master’s degree in Computer Science, Statistics, Life Sciences, or related field
>> 15+ years of experience in statistical programming and clinical data management
>> Strong expertise in SAS (Base, Macro, SQL, ODS, STAT, Graph), CDISC standards (SDTM, ADaM, define.xml), Regulatory submissions (FDA, global agencies)
>> Hands-on experience with Python (Pandas) and/or R (admiral, Shiny), Cloud platforms (AWS/Azure)
>> Strong understanding of GxP and clinical compliance frameworks
Bachelor's or Master's degrees
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