Job Description
SDTM/ADaMModel and IG
Thoroughunderstanding of SDTM/ADAM concepts and challenges. Good hold on the TAUG’s andrelated guidelines. Hands on experience in implementing SDTM/ADAM conceptsacross TA’s and various phases of clinical trains. Good understanding onprevious versions on SDTM/ADAM guidelines.
StudyReporting
Suggest creative solutionapproach for various business requirements to solve complex SDTM/ADaM Mappingand Programming problems (. creates modular reusable code, develops standardcode or utilities, and designs interconnected programs. Review and authordocuments related to deliverables (User Guide, CDARS Mapping Specification,OCF, Test Plans,SAS Logs andPrograms). Good understanding of all study documents including Protocol, SAP,Mock Shells, LOT, Analysis plan etc. Hands on experience of development andreview of study specific tables, listings and figures for various phases ofclinical trials and across TA’s.
SA...
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