The Senior Statistical Programmer II provides technical guidance on clinical project teams. Work is performed on the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. In addition, the Senior Statistical Programmer II participates in departmental and cross functional technology development and process improvement initiatives. Key Duties and Responsibilities: Codes complex SAS programs (including Macro language, SAS/STAT and SAS/GRAPH) for applications designed to analyze and report complex clinical trial data and for electronic review, exchange, transformation, and submission of data in CDISC SDTM format; consistently meeting objectives of the study. Performs quality control checks of SAS code and output produced by other Statistical Programmers. Demonstrates proficient knowledge of clinical development and medical data. Solves clinical trial reporting problems and has a proven technical proficiency in supporting daily operations and ensuring that project tasks are completed accurately with limited supervision. Creates CDISC data sets by transforming various raw data sources, including different Electronic Data Capture (EDC) databases and Interactive Web Response Systems (IWRS), tables, figures, and listings reporting and submitting the results of clinical trials for investigational medications. Works with all types of coding dictionaries (MedDRA and WHODD) commonly used by the pharmaceutical industry. Works in a team environment providing technical leadership and solving clinical trial reporting problems within budget and customary timeline constraints while assuring high quality standards. Knowledge and Skills: Competence with SAS. Working knowledge of CDISC Standards. Working knowledge of clinical trials. Effective communication (written and verbal) skills to exchange complex information with others. Education and Experience: Bachelor's/Master's degree in a Scientific Discipline. Typically requires 2+ years for M.S or above and 5+ years for B.S. of work experience in Biotech, Pharmaceuticals or Clinical Research Organization.
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