Join to apply for the Clinical SAS Programmer role at Katalyst CRO . Responsibilities include: Attending multi-disciplinary team meetings, representing the programming function. Creating, reviewing, and approving programming plans at study and project levels. Providing input on key study-related documents (e.g., CRFs, Data Management Plan, SAPs). Creating or reviewing CDISC-compliant datasets and documentation for regulatory submissions. Developing software systems for displaying study data as tables, listings, and graphs for regulatory submissions. Assisting statisticians with algorithm suggestions for analysis requests. Developing software validation procedures and test plans. Creating and maintaining archives of software, outputs, and analysis files. Maintaining department SOPs related to clinical programming. Reviewing draft clinical reports, journal articles, slide presentations, and other documents for accuracy. Overseeing work of internal contract programmers and external vendors. Providing time and resource estimates for project planning. Requirements include: Bachelor's degree in a relevant scientific field; master’s preferred. Minimum of 7 years experience in clinical trial software development using SAS. Proficiency in SAS programming; knowledge of additional languages is a plus. Good understanding of statistics and drug development processes. Experience as a lead programmer for NDAs/BLAs. Experience overseeing internal and external programming resources. Knowledge of pharmacokinetics/pharmacodynamics modeling is a plus. Familiarity with CDISC standards, SDTM, and ADaM models. Strong verbal and written communication skills. #J-18808-Ljbffr
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