Principal Biostatistician

Job Summary

Working remotely on a full-time basis, the Principal Biostatistician will implement diverse statistical tasks throughout the clinical trial process, from study design to final analysis and reporting, while collaborating closely with clients in the pharmaceutical industry.

Key responsibilities

• Implement statistical methodologies and contribute to study design, protocol writing, and analysis reporting
• Manage statistical tasks across multiple clinical trials, ensuring quality and accuracy in health outcomes
• Collaborate with clinical leadership and clients, providing expertise in statistical modeling and regulatory compliance

Required qualifications

• PhD or MS in Biostatistics, Statistics, or Mathematics; PhD is highly preferred
• Minimum of 10 years of experience in clinical trials, specifically as a study lead
• Experience with Phases 2 & 3 clinical trials and study design, including protocol and SAP development
• Strong statistical modeling experience and client/vendor management skills
• Expert-level proficiency in SAS programming and familiarity with regulatory authorities (FDA, NIH, EMA, etc.)