Description
SUMMARY * 6 years of experience as a Statistical Programmer in Clinical trials of Pharma Industry. * Expertise in SAS programming features like BASE SAS, SAS/MACROS, SAS/STAT, SAS/GRAPH, SAS/SQL, and ODS. * Skilled in generating reports featuring various SAS procedures, like Proc Report, Proc Summary, Proc Freq, Proc Mean, Proc Transpose, Proc sort, Proc Univariate, Proc Datasets, Proc Compare, Prco SGPLOT, and Proc SQL. * Experience in using SAS to read, write, import and export to another data file formats, including delimited files, and Spreadsheets. * Experience in cleaning and resolving data issues and merging data from various data sources into a single dataset. * Excellent knowledge in creating various global and local macro variables. * Experience in using SAS programming in analyzing the Clinical Trial Data and responsible for generating tables, listings and graphs. * Good working knowledge of clinical trials data like demographic data (DM), adverse events (AE), serious adverse events (SAE), laboratory data (lab data), Concomitant medication (CM), physical examination and vital signs. * Strong working knowledge in CDISC and MedDRA regulated environment. * Experience in generating SDTM datasets and in derivation of ADaM datasets by implementing CDISC Standards. * Strong academic background in drug development process- clinical trial process, collection (paper CRF, eCRF (EDC, RDC), analyses, presentation of data and in understanding Code of Federal Regulations (21CFR) Part 11, GCP, ICH, FDA and other regulatory guidelines. * Strong working knowledge in CDISC and MedDRA regulated environment. * Extensive experience in creation of SDTM datasets and in derivation of ADaM datasets by implementing CDISC Standards. Good command on ODM and Define.XML. * Experience in PK (Pharmacokinetic) and PD (Pharmacodynamic) analysis.
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