Principal Biostatistician

Job Summary

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

Key Responsibilities

• Collaborates with various teams to design post-approval studies and writes statistical sections of study protocols
• Contributes to the preparation of statistical analysis plans and provides statistical guidance on ongoing studies
• Reviews and interprets study data, contributing to scientific articles and regulatory documents

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
• Extensive experience programming in SAS and working on data analysis with clinical studies databases
• Experience with post-approval observational and clinical studies
• Understanding of ICH GCP and general knowledge of industry practices and standards
• Experience with CDISC, including SDTM, ADaM, and CDASH