• SAS Certified Programmer; very strong experience of Base SAS, SAS/STAT, SAS Macros, and SAS/SQL on Windows, SDD, Mainframe & Unix• Extensive knowledge in developing macro utilities for CDISC SDTM conversion, Define.xml, Reporting and Medidata Rave etc• Extensive knowledge in managing and building the EDC system using Omnicomm• Extensive knowledge in Clinical Trials in various therapeutic areas such as Oncology, Neuroscience, Respiratory, Diabetes, Infectious/Parasitic Diseases and Orthopedic trials etc• Extensive Knowledge in the Statistical Analysis Plan (SAP) validation• Extensive experience in leading & managing the project team across globe• Thorough knowledge of 21 CFR part 11 • Extensive Knowledge in CDISC SDTM conversion application development• Organizing Data Entry Application from CRF and CRF Annotation• Developed SAS Macros for Statistical analysis and reporting purpose.• Extensive knowledge in extracting data from various EDS applications• Developed SOPs and Guidelines for company related documents• Developed the project estimates for TFLs development and Data management projects• Provided support for preparing proposal for acquiring new clients• Extensive experience in preparation of reports, tables, listings and graphs using clinical data• Expertise in using various SAS procedures such as univariate, SQL, Freq, Means, GLM, ANOVA, Lifetest, Compare, Sort, Transpose, Report, and ODS etc• Recruit, interview and hire the SAS programmers for the team