Responsibilities: 5 years of Statistical Programming experience in the Pharmaceutical, Biotechnology, and/or Contract Research Industry. Bachelor's and/or master's degree in Statistics, Biostatistics, Computer Science, Mathematics or Life Sciences. High competence in using SAS/Base, SAS/Macro, SAS/STAT, etc. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of: CDISC SDTM and ADaM principals; Relational Databases; Good Clinical Practice principals; Good Programming Practice principals; 21CFR Part 11 Standards principals. Good knowledge of industry standards including CDISC data structures (SDTM and ADaM). Experience in validating Adams and TFLs. Strong knowledge on SAS macros and able to work on modifying/existing SAS programs. Great interpersonal skills. Excellent communication skills (written and verbal). Strong attention to detail. Highly organized. Requirements: Experience with creating PK datasets and outputs (ADPC and ADPP), generating datasets for PK analysis, etc. Experience in CNS. Nephrology background. Submission experience. Experience with leading studies. Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio. Experience with all clinical phases I, II, III and IV of trails. Katalyst Healthcares and Life Sciences
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