Principal Biostatistician Consultant

Job Summary

Providing statistical leadership for oncology clinical development programs, the remote Principal Biostatistician Consultant will manage Phase I-III clinical trials, develop statistical analysis plans, and collaborate with cross-functional teams to support regulatory submissions.

Key Responsibilities

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I-III)
• Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs)
• Collaborate with clinical development, data management, programming, regulatory, and medical teams

Required Qualifications

• PhD or MS in Statistics, Biostatistics, or related field
• 8+ years (MS) or 6+ years (PhD) of industry experience in biostatistics
• Strong experience in oncology clinical trials
• Proficiency in SAS and/or R
• Strong knowledge of CDISC standards (SDTM, ADaM)