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SDTM SAS programmer

Sms Global Technologies Inc

This is a Full-time position in Pflugerville, TX posted July 19, 2021.

Job DescriptionThe CDISC SDTM SAS programmer will work with study teams of one of the major pharma to drive and/or support quality and timely deliverables of SDTM artifacts in disease areas such as oncology, vaccine, cardiovascular, inflammation, pain and responsibilities may include, but is not limited to:Design the SDTM specification as per the CDISC SDTM IG and Sponsor standards and ensure they meet downstream ADaM and reporting requirements.Annotate CRFs and Review annotated CRFs in accordance with sponsor guidelines and appropriate metadata to reflect tabulation datasets.Proficient in programming languages and demonstrated proficiency in using SAS on Linux to produce SDTM datasetsHands on experience using Pinnacle21 to generate and validate SDTM deliverablesMaintain high quality deliverables with validation and resolution of issues surfaced in Pinnacle21.In-depth knowledge of FDA/ICH guidelines, industry/technology standard practices and good programming practicesExperience Required:Advanced degree in Life Sciences, Mathematics or Computer Sciences or comparable professional experienceExcellent Expertise in CRF design following CDISC best practices.Deep understanding of the CDISC foundational standards and available TAUGs.Proven experience using CDASH, SDTM, NCI EVS Controlled Terminology.Very good programming skills (especially SAS)UNIX/LINUX skills are important.Comprehensive knowledge of ICH-GCP5 or more years of hands-on experience with writing specifications for all types of SDTM domains for both Core and Efficacy across TAs.Experience / or in-depth knowledge in clinical development / pharmaceutical industry and processesUnderstanding of regulatory data submission processes (Define.xml, cSDRG)*This is remote opportunity open to any North America home-office

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