Responsibilities: Performing data manipulation, analysis, and reporting of clinical trial data for both safety and efficacy (ISS/Client) utilizing SAS programming. Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures ( TLFs). Production and QC / validation programming. Ability to program from scratch and able to handle complicated domains and TLF's. Ability to read and apply protocol and SAP. Demonstrate good understanding of the endpoints and data collection. Generating complex ad-hoc reports utilizing raw data. Requirements: Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, or related field. At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above. Study lead experience, preferably juggling multiple projects simultaneously preferred. Strong SAS data manipulation, analysis, and reporting skills. Solid experience implementing the latest CDISC SDTM / ADaM standards. Strong QC / validation skills. Proficiency in Efficacy analysis. Ability to provide quality output and deliverables in adherence with challenging timelines. Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners. Katalyst Healthcares and Life Sciences
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