Have over 5 years of experience in SAS applications used in clinical trials and research on WINDOWS environment. Had been responsible for generating & validating TLFs for safety and efficacy analysis (including ISS & ISE), creating SDTM and ADaM datasets for reporting (CDISC conversion), extraction of data from EDC into SAS data sets and/or transport files, and definition of .xml files for CTDs for FDA submissions. Have been trained in eCRF design, edit check build and validation using Medrio & Merge eClinical. Therapeutic area experience includes Gynecology, Immunology, Neurology and Oncology.