Biostatistician II

Job Summary

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