Requires a Masters degree in Statistics, Computer Science, Pharmaceutical Administration, or related field and 5 years of experience processing clinical trial data in the biotechnology, pharmaceutical or health related industry. Must have the following experience Interpreting, modifying, and adapting procedures, practices, and methods in accordance with existing policies and standards for application to specific problems or tasks; SAS programming skills in a clinical data environment; Relational database structure, SAS, CDISC data structures Base, Stat, Macro, graph; Reporting systems utilizing multiple data delivery applications; Implementing standardization methodology; Pharmaceutical clinical development i.e. understanding safety deliverables, efficacy analysis and providing programming support needs for BLA and other regulatory submissions; Developing and executing user requirements, validation plans, and operational and performance protocols; Process improvement for CDISC SDTM standardization and development automization; Developing define.xmldefine.pdf along with Reviewers guides for sBLA submissions; Developing CDISC datasets and Reports for pooling of multiple studies for Integrated Safety Summary ISS submission to regulatory authorities; Overseeing vendor activities for the development of CSDIS SDTM datasets, Performing Quality Control on vendor deliverables; and Communicating with crossfunctional teams to understand and implement any regulatory requests from various health authorities like FDA, EMA, or HC.br br Per Executive Order, Regeneron requires all U.S. employees to be fully vaccinated against COVID19, unless they are legally entitled to an accommodation for medical or religious reasons.
Categories: eb3
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