Senior Biostatistician

Job Summary

A company is looking for a Senior Manager, Biostats.

Key Responsibilities

• Serve as study biostatistician on development programs and multiple studies
• Author statistical analysis plans and oversee the generation of AdaMs and TFLs
• Plan and implement statistical analyses and provide statistical support for regulatory submissions

Required Qualifications

• Preferably PhD with at least 5 years of experience or Master with 10 years of experience
• Demonstrated understanding of Phase I to Phase IV drug development
• Strong knowledge of statistical analysis principles and techniques
• Experience with statistical analysis software SAS and R
• Experience in NDA/BLA submissions is a plus