Senior Principal Biostatistician, Study Lead – Oncology

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and offer statistical support for clinical trials, predominantly in the field of Oncology.

• Serve as the principal statistician for designated studies, managing statistical strategies and deliverables.

• Draft and evaluate Statistical Analysis Plans (SAPs), Analysis Database Specifications (ADS), and the statistical segments of clinical study reports.

• Review and interpret analysis results, ensuring precision, quality, and compliance with regulatory standards.

• Collaborate with Clinical, Programming, Data Management, and Regulatory teams.

• Provide direction and supervision to statistical programmers when necessary.

• Convey statistical concepts, findings, and risks to both technical and non-technical audiences.

• Ensure compliance with FDA, ICH, GCP, and company Standard Operating Procedures (SOPs).

⛳️ Requirements

• MS or PhD in Statistics, Biostatistics, or a related discipline.

• Extensive experience in Oncology studies.

• Practical experience in drafting Statistical Analysis Plans (SAPs).

• Practical experience in writing Analysis Database Specifications.

• Experience in reviewing and interpreting analysis outcomes.

• Proficient in SAS programming (hands-on experience or strong working knowledge).

• Exceptional written and verbal communication capabilities.

• Experience in a CRO and/or pharmaceutical/biotech setting.

• Preferred: Experience leading Phase II–III clinical trials.

• Preferred: Previous interaction with regulatory bodies.

• Preferred: Experience mentoring junior statisticians or programmers.

🏝️ Benefits

• Opportunities for professional growth.

• A fulfilling and rewarding career.

• Ongoing training and development.

• Commitment to equal opportunity, diversity, and inclusivity.