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)
Originally posted on Himalayas
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