Responsibilities: Independently develops SAS or other programs, and specifications (e.g. SDTM, Adam), for use in study or other analyses, such Integrated Safety Summaries. Must be able to program defensively, check results, and consistently produce accurate output. Independently verifies other programmer's results. Serves as oversight, point-of-contact, and quality control for datasets in SDTM and Adam format as well as tables, listings, and figures (TLFs) produced by CROs, including clear documentation of the process that was followed in the form of specifications, trackers, and checklists. dheres to FDA regulations and company policies regarding training records, guidelines, and SOPs. Supports ad-hoc requests as needed. Works on multiple tasks at the same time and prioritizes tasks to meet business needs. Trouble-shoots technical and project issues. Helps with the infrastructure development of the department. ssists team to ensure timelines for the study and/or project are met. ssists with training new employees and contractors, on study specifics and departmental programming conventions and standards. Communicates with outside departments and/or CROs. Requirements: 3 years' experience in statistical programming with clinical data and SAS 2 years of Oncology experience Strong SAS programming skills required, with proficiency in SAS/Base, SAS/Stat and SAS Macros UNIX, S-Plus, CDISC, and SAS/GRAPH experience desirable. bility to communicate verbally and in writing in a clear and timely manner. Experience in Biotech/Pharmaceutical industry preferred. BS/BA degree in related discipline and seven years of related experience; or, MS/MA degree in related discipline and five years of related experience; or, Extensive experience in relevant industry/profession and area of specialization. Has complete understanding and wide application of technical principles, theories, concepts, and techniques. Has good general knowledge of other related disciplines. pplies strong analytical and business communication skills. Katalyst Healthcares and Life Sciences
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