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 Statistical Analysis Plans (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 include independently drafting Statistical Analysis Plans (SAPs) and defining shells for clinical study reporting.
You will communicate effectively with sponsors and cross-functional teams.
You will review Tables, Listings, and Figures (TLFs) for statistical accuracy and clarity.
Conducting ADaM specification reviews to ensure consistency and compliance with clinical data standards is also part of the role.
You will identify issues proactively within SAPs, specs, and outputs, providing detailed and thoughtful insights.
Ensuring quality, traceability, and adherence to regulatory and clinical guidelines is crucial.
Requirements:
Candidates must have 8–10+ years of experience as a Biostatistician.
A proven ability to independently draft SAPs and shells is required.
Excellent communication skills and the ability to interact confidently with sponsors are essential.
Strong attention to detail and analytical thinking are necessary for this position.
Hands-on experience reviewing TLFs and ADaM specs is required.
Candidates must be comfortable working remotely with consistent overlap in US time zones, preferably in the morning to early afternoon.
Fluency in English, both spoken and written, is mandatory.
Benefits:
This position offers a long-term contract opportunity in a dynamic and collaborative environment.
You will have the chance to work on impactful clinical trial projects.
The role allows for remote work flexibility while maintaining a connection with global stakeholders.
You will gain valuable experience and enhance your skills in biostatistics and clinical trial support.