Minimum 6 Years SAS Programming Experience supporting Phase 1-3 clinical trials in CRO or pharmaceutical industry.
Solid understanding of SDTM and ADaM implementation guidance, minimum 4 years of work experience on creating and validating ADaM datasets.
Experience with creating ADaM data specifications; such as ADSL, ADAE, BDS, controlled terminology, etc.
Experience on creating Tables, Listing and Figures for clinical study report using proc report or data _null_.
Knowledge of regulatory submission process, experience on creating ISS, ISE ADaM datasets and TLFs is a plus.
Efficient in using Excel and Word documents.
Excellent communication skill.
Experience in Immunology therapeutic area is preferred, A strong candidate, with experience in another TA, will certainly be considered.
Education – BS in Statistics, Computer Science or a related field with 6+ years of relevant experience OR MS in Statistics, Computer Science or a related field with 4+ years of relevant experience
Additional Information
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