Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician FSP in Medical Affairs.

Key Responsibilities

• Leads statistical support for post approval value evidence generation and reimbursement submissions
• Conducts post hoc analyses to support publications and presentations
• Develops statistical sections of study protocols and statistical analysis plans

Required Qualifications

• PhD in Biostatistics, Statistics, or equivalent with at least 3 years of pharmaceutical biostatistics experience; or MS with at least 5 years of relevant experience
• Strong SAS programming experience and ability to deliver analysis outputs without programmer support
• Extensive experience working on data analysis with clinical studies databases
• Experience working on post-approval observational and clinical studies
• Understanding of ICH GCP and general knowledge of industry practices and standards