- 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
All your information will be kept confidential according to EEO guidelines.