• 7-10 years Pharmaceutical/CRO experience as a SAS programmer supporting clinical trials for regulatory submissions. • Demonstrated knowledge in programming environments, systems and networking as it relates to the pharmaceutical industry. • Have in-depth understanding of clinical data structure as well as relational databases • Demonstrated proficiency in using SAS • Demonstrated skills in using software tools and applications, e.g., MS office, XML, HTML, etc. • Have an understanding of regulatory requirements pertaining to technology, systems, and standards. • Ability to research new technologies and ensure alignment with regulatory agencies and industry standards • Demonstrated ability in the handling and processing of upstream data, e.g., multiple data forms, workflow, eDC, SDTM. • Demonstrated ability in providing outputs to meet downstream requirements, e.g., ADaM, Data Definition Table, e-submission
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