Ensure that the computerized systems are fit for intended use and in compliance with all applicable regulations throughout the system life cycle, including planning and proposing validation strategies, preparing all the validation documentation in compliance including test cases, defining acceptance criteria, executing tests and reviewing results, etc.Validation Protocol generating and executed (IQ, OQ and PQ)Follow up all the issues found during validation and communicated with the customer QA.

Analyzed, tested, documented, and maintained SAS programs and macros to generate ADaM SAS datasets, data listing, tables, and graphical displays of clinical trials data by Proc report, Proc tabulate, SAS/Graph and ODS graphics.Applied statistics and biostatistics knowledge to write and edit statistical programs to evaluate data. Ensured accurate production of SAS extract views for data analysis and reporting.