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Job Description Responsibilities Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
Specific Tasks Document Control (In the absence of a Document Controller) • Prepares and maintains the Document Control Policy which shall contain the policies and guidelines on the organizations’ policies and procedures manual (which might contain,
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