8–10+ years of experience as a Biostatistician., Proven ability to independently draft Statistical Analysis Plans (SAPs) and shells., Hands-on experience reviewing Tables, Listings, and Figures (TLFs) and ADaM specifications., Excellent communication skills and fluency in English..
Key responsibilities:
Draft and define shells for clinical study reporting.
Communicate effectively with sponsors and cross-functional teams.
Review TLFs and ADaM specifications for accuracy and compliance.
Identify issues proactively within SAPs, specifications, and outputs.
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NTD Software is a Mexican company located in Guadalajara, Jalisco, known as "the silicon valley of Mexico." We help both startups and big companies by finding the right people to join their team and creating digital solutions using the latest or well-established programming languages and tools. Our expertise is in building software from the ground up and expanding our clients' existing teams, allowing us to work with businesses globally.
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
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).
Required profile
Experience
Level of experience:Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.