Job Description

Senior Biostatistician

We are looking for an experienced Senior Biostatistician to join our team on a long-term contract supporting clinical trial projects. This role requires solid statistical expertise, the ability to independently develop SAPs and shells, and close collaboration with sponsors. You'll be working with global stakeholders, so availability to overlap with US business hours is essential.

Key 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.

Qualifications

• 810+ 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).

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