Join to apply for the SAS Programmer role at Katalyst CRO . Overview Responsibilities Develop and validate programs that create datasets conforming to CDISC standards. Drive the creation of Tables, Listings, and Figures for analysis purposes. Lead programming projects as warranted by study complexity, ensuring adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. Mentor junior programmers and represent Statistical Programming in meetings with internal and external clients. Integrate statistical concepts with SAS Programming to support analyses efficiently. Support development of technical programming specifications for SDTM, ADS or ADaM standards. Independently develop and/or validate programs that generate SDTM and analysis datasets based on Alexion or ADaM specifications. Support development and validation of technical programming specifications for tables, listings, and figures/graphs based on Protocol and SAP. Independently develop and validate programs that generate tables, listings, and figures/graphs using Alexion specifications. Manage external vendors and contract programmers. Provide project progress updates of programming activities. Review, maintain, and approve protocol-specific documents as necessary. Provide guidance and mentoring to peer, junior-level Programmers and contract staff. Support project leadership ensuring that department standards are implemented in all studies. Contribute ideas toward the optimization of standard operating procedures. Lead team meetings when appropriate. Independently and collaboratively resolve problems. Qualifications Statistical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry. Develop and validate technical specifications and programs for safety and efficacy analysis datasets, tables, listings, and figures/graphs. Clear communication of processes and standards with management and team members. Proficiency in SAS/Base, SAS/Macro, SAS/STAT. Knowledge of SAS/Graph, and SAS/SQL. Knowledge and implementation of SDTM and ADaM principles. Relational Databases. Good Clinical Practice principles. Good Programming Practice principles. 21CFR Part 11 Standards principles. Integrated Summary Safety/Efficacy Analyses. Safety data and Coding Dictionaries (MedDRA and WHODD). ICH eCTD format. Seniority level Mid-Senior level Employment type Full-time Job function Information Technology Industries Biotechnology Research and IT Services and IT Consulting #J-18808-Ljbffr Katalyst CRO
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