Senior Biostatistician

Summary

Join our team as a Senior Biostatistician for a long-term contract supporting clinical trial projects. This role demands strong statistical skills, independent SAP and shell development, and close collaboration with sponsors and global stakeholders. Availability during US business hours is crucial. Key responsibilities include drafting Statistical Analysis Plans (SAPs), defining shells for clinical study reporting, reviewing TLFs, conducting ADaM specification reviews, and ensuring quality and regulatory compliance. The ideal candidate will possess 8-10+ years of biostatistical experience, proven SAP and shell drafting abilities, excellent communication skills, and a keen eye for detail. Remote work is possible with overlapping US business hours.

Requirements

• 8–10+ years of experience as a Biostatistician
• Proven ability to independently draft SAPs and shells
• Excellent communication skills and ability to interact confidently with sponsors
• Strong attention to detail and analytical thinking
• Hands-on experience reviewing TLFs and ADaM specs
• Comfortable working remotely with consistent overlap in US time zones (morning to early afternoon preferred)
• Fluent in English (spoken and written)

Responsibilities

• Independently draft Statistical Analysis Plans (SAPs) and define shells for clinical study reporting
• Communicate effectively with sponsors and cross-functional teams
• Review Tables, Listings, and Figures (TLFs) for statistical accuracy and clarity
• Conduct ADaM specification reviews to ensure consistency and compliance with clinical data standards
• Identify issues proactively within SAPs, specs, and outputs, providing detailed and thoughtful insights
• Ensure quality, traceability, and adherence to regulatory and clinical guidelines