PROFESSIONAL SUMMARY · SAS certified Base Programmer with 7+ years of IT experience including 5+ yrs of experience in Statistical Analysis, reporting and Clinical Data Management. · Domain knowledge in Pharmaceuticals and Health care industries. · Good Understanding of Clinical Trial protocol and CRF's annotation and participated in Review of protocols, CRF's, test databases and Statistical Analysis Plans. · Experience with Clinical study methodologies, Clinical trial phase I – phase IV. · Experience in handling complex processes using SAS/BASE, SAS/MACROS, SAS /SQL, SAS/GRAPH, SAS/STAT, SAS/ODS, SAS/ACCESS and SAS Enterprise Guide. · Knowledge in Development and Customization of SAS Scripts for Extraction, Transformation, loading and Data Analysis. · Have experience in clinical data analysis: analyzing clinical data, derived datasets, creating tables, generating listings, reports and graphs. · Good comprehension of CDISC guidelines, Good Clinical Practices (GCP), International Conference of Harmonization (ICH) and other regulatory guidelines. Knowledge on Good Clinical Data Management Practice (GCDMP). · Good knowledge of Clinical Trials Data like Demographic Data, Adverse Events, Serious Adverse Events, Vitals, Laboratory Data. · Experience in programming for Integrated Summaries of Efficacy (ISE) and Safety (ISS). · Good understanding of statistical concepts and knowledge of regulatory environment and FDA/ ICH guidelines. · Experience in providing Clinical Study reports (CSR), compliant with FDA guidelines in 21 CFR Part 11 for electronic submissions. · Good command in using import/export wizard, PROC IMPORT and PROC EXPORT, SAS/ACCESS, SAS/SQL, DDE(Dynamic Data Exchange) to import different types of external data files (csv, xls, txt, etc) into SAS library and export SAS datasets into different types of external data files. · Good command in producing tables and listings with reporting using SAS procedures such as SAS PROC REPORT, PROC TABULATE. · Producing data in various output formats including HTML, RTF, PCL, PDF, PS using ODS (output Delivery System). · Changing datasets using TRANSPOSE Procedure and combining Data sets horizontally with DATA Step Match-Merge, SQL Joins. Combining datasets vertically using SET, UPDATE statements and set Operators. · Experience in Query Optimization, Debugging, and Tuning and Improvising performance of the applications. · Performed Data Analysis and validation using Edit checks. · Experience in Modifying existing SAS programs and creating new SAS Programs using SAS Macro to improve ease and speed of modifications as well as consistency of results. · Using the AUTOCALL and STORED COMPILED Macros Facility. · Create project specific MACROS and custom FORMATS. · Tracking changes to a data set by Initiating and Controlling the Audit Trails. · Knowledge of Initiating and Processing Generation Data Sets and defining Integrity Constraints on tables. · Acted as liaison between research scientists, statisticians and SAS software programmers. · Exceptionally well organized. Ability to quickly adapt to new applications and platforms. · Strong work ethics, analytical and communication skills and willingness to work hard. | 
