Statistical Programmer II

We’re hiring experienced Statistical Programmers II to support pivotal clinical studies in a dynamic, fast-paced environment. You will work with cross-functional teams to deliver high-quality statistical outputs using ADaM standards and generate TLFs (Tables, Listings, and Figures) for clinical trial submissions.This role offers full remote flexibility across LATAM.

Core Responsibilities

• Develop ADaM datasets and generate TLFs for pivotal Phase II/III clinical studies
• Identify inconsistencies or issues during programming related to specs, SAPs, and shells
• Collaborate closely with biostatisticians and clinical teams to ensure data quality and traceability
• Apply industry-standard best practices and CDISC ADaM guidelines
• Contribute to continuous improvement and documentation of processes
• Support safety and efficacy data programming (beyond validation)

Must-Have Qualifications

•  At least 8+ years of experience in ADaM/TLF;
• Work in detail (e.g, during programming, try to identify any issues on spec/sap/shell instead of just following; identify inconsistency between spec/sap/TLF).
• Good at SAS syntax and SAS macros;
• Has experience on the safety ADaM/TLF production side instead of the validation side;
• Has some knowledge of the ADaM CDISC guideline
• Has some (6 hours at the beginning, after familiar, then maybe 3-4 hours east coast between 9 am-12 pm) overlap time with US time

Nice to Have

• Experience developing efficacy ADaM datasets
• Experience generating efficacy TLFs
• Strong knowledge of ADaM specifications
• Proven leadership in pivotal studies (Phase II/III)

If you’re passionate about delivering clean, compliant, and analysis-ready clinical datasets—and thrive in a collaborative, remote-first environment—this could be your next move!