Biostatistician II
Virtual Vocations Inc
As the lead Biostatistician on assigned studies, the full-time remote Biostatistician II will manage statistical analyses, develop statistical plans, and serve as the primary statistical contact for project teams while ensuring compliance with regulatory guidelines. Key responsibilities Act as the primary statistical contact for internal and external project team members Develop and assist in the creation of Statistical Analysis Plans (SAPs) and Interim Analysis Plans (IAPs) Perform statistical analyses and validate derived datasets and tables according to department SOPs Required qualifications Master's degree in Biostatistics, Statistics, or a related field Two years of related biostatistics experience in a pharmaceutical or CRO environment Experience with CDISC SDTM and ADaM dataset mapping Knowledge of ICH guidelines and regulatory requirements related to biostatistics Experience with BLA/NDA submissions and regulatory representation
Vacancy posted 2 days ago
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