Develop and maintain datasets as per the CDISC (SDTM and ADaM) standards; Extract data from various databases; Develop and maintain programs to analyze the data and produce reports consisting of Tables, Listings and Graphs that are generated from the available databases; Apply Programming Development Life Cycle (PDLC) principles; Develop programs using SAS(Statistical Analysis Software) and SQL; Perform Programming using SAS software analyzing the clinical trial data to produce the outputs for the clinical trial report; Prepare specifications and process flow diagrams, and develop programming code logic flowcharts; Write specifications for the analysis datasets and report (Tables, Listings and Graphs) generation; Prepare reports to assist management in problem analysis, and submit recommendations for solution; Create primary and validation programs; Develop, test, debug and deploy the programs in coordination with other line functions as per standard operating procedures (SOPs); Maintain study documentation; Document and revise system design procedures, test procedures, and programming standards; Analyze user/customer needs and software requirements to determine feasibility of design within time and cost constraints; Create analysis files (datasets), and reports Tables, Listings and Figures; Consult with customers about software design, maintenance, enhancement and customization; Store, retrieve, and manipulate data for analysis and reporting; Expand or modify existing programs for efficiency and reusability; and Work on other ad hoc tasks as assigned.
1 - 3 years Pharma experience supporting clinical trials Working experience for clinical data; Familiar with trial analysis Prior experience with SAS / R
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