Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician, FSP, Late Phase.

Key Responsibilities

• Collaborate with multi-disciplinary project teams to establish project objectives and timelines
• Write statistical sections of clinical trial protocols and author statistical analysis plans
• Monitor project activities and provide guidance to programmers on analysis dataset specifications

Required Qualifications

• PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience, or MS with 7+ years
• At least 3 years of Phase 2/3 clinical trial experience
• Ability to use R or SAS for efficacy and safety analyses
• Understanding of ICH GCP, ICH E9, and industry practices
• Experience with CDISC standards including SDTM, ADAM, and CDASH