Principal Biostatistician Consultant

Job Summary

Working remotely, the Principal Biostatistician Consultant will manage protocol development, provide statistical oversight for studies, and ensure data accuracy while collaborating with clients in the Respiratory & Immunology team.

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 manage activities of statisticians across projects

Required qualifications:

• MS or PhD in Statistics, Biostatistics, or a related field, with relevant experience (PhD with 2-4 years or MS with 5-7 years)
• Strong SAS programming skills
• Experience in Respiratory & Immunology therapeutic area, specifically with asthma studies
• Demonstrated understanding of statistics, drug development processes, and FDA regulations
• Experience in pharmaceutical or CRO environments, particularly with clinical trials and regulatory agency interactions