Statistical Programmer II

Summary

Join our team as an experienced Statistical Programmer II to support pivotal clinical studies. You will collaborate with cross-functional teams to produce high-quality statistical outputs using ADaM standards and generate TLFs (Tables, Listings, and Figures) for clinical trial submissions. This role offers complete remote flexibility across LATAM. The position involves developing ADaM datasets, generating TLFs for Phase II/III clinical studies, identifying programming inconsistencies, and collaborating with biostatisticians and clinical teams. You will apply industry best practices and CDISC ADaM guidelines, contribute to process improvement, and support safety and efficacy data programming. The ideal candidate will have extensive experience in ADaM/TLF and a strong understanding of SAS programming.

Requirements

• 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

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)

Preferred Qualifications

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

Benefits

This role offers full remote flexibility across LATAM