Sometimes the data is taken from its raw state and transformed directly into TLGs, but most often the STAT programmer engenders analysis data sets from which they can facilely engender the compulsory output documents for the CSR. The second type of clinical programmer is the statistical programmer (STAT) who takes the data that is cleaned and transformed by the DM programmer and engenders tables, listings, and graphs (TLG) for the clinical study report (CSR). Thus, another aspect of the job is to write programs to check the data against the standard and run the programs whenever an incipient study is about to be analyzed. Determinately, when all the data has been transformed, the DM programmer must engender a convey file that will be sent to the regulatory agency that will review the submission data.

In the process of transforming the data, the DM programmer must make sure that the output conforms to the standard and is compliant as well as valid. This standard format could be the CDISC Study Data Tabulation Model (SDTM) that is requested by regulatory agencies such as the FDA for submission of an incipient compound, or it could be a sponsor’s own standards. The main goal is always to access the data, manipulate and transform it, analyze it, and report on it. A programmer can specialize in data management (DM) programming and spend most of the time cleaning the data through edit checks and the engendered of patient listings and profiles.Īnother task of the DM programmer is to transform the data from its raw format into a standard format. As a clinical programmer, there are many paths available.

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