Hands-on skills in legacy data conversions to CDISC SDTM data sets. Working experience in generating CDISC ADaM data sets and TLFs to support clinical study reports, ISS or Client. Preparation of electronic submission data package including define.xml for FDA submissions such as NDA or BLA is a plus. Strong working experience with Oncology. BS/MS in statistics or related science with 5+/3+ years of experience in the pharmaceutical industry.
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