Responsibilities: Serves as the primary project team representative, delegating work as appropriate Generates SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains Generates analysis data sets, tables, figures, and listings to support the analysis of clinical trials dat Reviews output across programs to ensure consistency Reviews maintains and approves study documents per standard procedures Provides programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests Programs, tests, and documents global utility programs and tools in accordance with standards and validation procedures Provides technical expertise to the development of programming standards and procedures, technical expertise in the areas of analysis and reporting Participates in the development and/or maintenance of departmental procedures and standards Requirements: BS/BA degree in computer science, mathematics, statistics, or related discipline and 5+ years' experience in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph). In addition, you must have at least three years of experience serving in a supervisory or lead capacity. Experience managing projects OR Demonstrates strong knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines Strong programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar Strong knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains Strong knowledge of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems Strong understanding of relational databases and experience working with complex data systems Understands key business drivers and uses this understanding to accomplish work Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas Katalyst Healthcares and Life Sciences
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