Offer summary

Qualifications:

Minimum 8 years of experience in ADaM and TLF programming., Proficiency in SAS syntax and macros., Experience in safety ADaM/TLF production, not just validation., Knowledge of CDISC ADaM guidelines..

Key responsibilities:

Develop ADaM datasets and generate TLFs for clinical studies.

Identify and resolve inconsistencies during programming.

Collaborate with biostatisticians and clinical teams to ensure data quality.

Apply industry standards and contribute to process improvements.

Job description

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!

Required profile