Principal Biostatistician Consultant

Job Summary

To support a client-focused oncology team, the remote Principal Biostatistician Consultant will manage protocol development, provide statistical oversight for studies, and ensure the accuracy and consistency of statistical analyses and reports.

Key responsibilities

• Develop protocols including study design, sample size calculation, and statistical analysis plans for assigned studies
• Provide statistical oversight to ensure quality and consistency with project requirements
• Mentor peers in statistical methodology and coordinate the activities of statisticians across projects

Required qualifications

• MS or PhD in Statistics, Biostatistics, or a related field; PhD with 2-4 years or MS with 5-7 years of experience required
• Strong proficiency in SAS programming
• Experience in Oncology therapeutic area
• Demonstrated understanding of the drug development process and relevant FDA regulations
• Experience in pharmaceutical or CRO settings, particularly with clinical trials and regulatory agency interactions