LIBNAME STATEMENT FOR EXCEL IN SAS ON MAC CODE
Involved in creating various SAS Reports satisfying the 21CFR-11 Code for Federal Regulations for electronic data submission.Worked with statisticians and data managers to provide SAS programming in analyzing clinical trials data and generated reports such as tables listing and figures for various phases of clinical trials regulatory submissions.Extensive experience in SAS/STAT procedures such as Proc Reg, Proc GLM, Proc Freq, Proc Meansand Proc Univariate.Expert in concatenating, interleaving and merging SAS datasets.Knowledge of industry regulations and standards guided by CDISC, and FDA including regulatory submissions.Involved in the process of generating TLG's Tables, Listings and Graphs for Integrated Summaries of Efficacy ISE and Safety ISS for FDA submission.Validating, testing, debugging SAS code to determine quality, completeness, and accuracy per specifications.Good in modifying existing SAS programs and creating new programs using SAS macro variables to improve ease and speed of modification as well as consistency of results.Proficient in Macro Facility, SAS Procedures, SAS formats, SAS functions, SAS statements, SAS Informats, Merging SAS Data sets, preparing data, producing reports, storing and managing data in SAS.Extensively involved in clinical data analysis and preparation of SAS Data sets, Reports, Tables, Listings, Summaries and Graphs according to the Standard Operating Procedures SOPs.Experience in analyzing and coordinating clinical data, generating detail summary reports and data validation using FDA regulation procedures.
Hands on Experienced in BASE SAS, SAS/STAT, SAS/MACROS, SAS/GRAPH, SAS/SQL, and SAS/ODS, SAS/ACCESS, SAS/Graph.8 years of experience as a SAS programmer/analyst in Clinical domain working in different therapeutic areas in trials ranging from Phase I-IV.
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