Highly skilled in statistical programming and reporting, data management and standardization professional with over 20 years in Bio-pharmaceutical and healthcare industries. Expertise in clinical trial design, regulatory compliance, data management and standards, EDC, CDISC/CDASH implementation, statistical design and reporting using SAS, data warehouse and mining, healthcare data analytic, electronic submissions (eCTD), selection and implementation of regulated clinical systems, clinical data bases and management, establishing healthcare data systems, technology planning and management, IIVR/IWR, randomization administration, electronic data capture, , FDA’s 21 CFR part 11, GC.