Principal Biostatistician

Job Summary

A company is looking for a Principal Biostatistician FSP for Early Phase.

Key Responsibilities

• Provide statistical support for drug development programs in early phases
• Collaborate with multi-disciplinary project teams and write statistical sections of clinical trial protocols
• Monitor project activities, interpret study results, and contribute to clinical study reports and regulatory documents

Required Qualifications

• PhD in Statistics, Biostatistics, or related field with 5+ years of industry experience, or MS with 7+ years
• Experience in Early Phase Oncology and regulatory submissions
• Ability to use SAS and/or R for efficacy analyses
• Understanding of ICH GCP and industry practices
• Experience with CDISC standards, including SDTM and ADaM