AI Data Annotation & Clinical Dataset Review (Biomedical/Clinical Data Project Experience), New York, NY
Conducted AI-assisted clinical dataset review for SDTM, ADaM, and TFL-style biomedical outputs against predefined statistical and clinical data specifications. Assessed whether AI-generated datasets conformed to expected variable structures, naming conventions, population flags, derivation logic, and analysis-ready formatting. Documented discrepancies by categorizing issues into mapping problems, statistical logic problems, or AI generation errors for downstream correction workflows. • Compared AI-generated outputs against source specifications, shells, and expected clinical programming logic. • Performed completeness, traceability, and cross-standard consistency checks across SDTM, ADaM, and TFL outputs. • Summarized review findings with possible root causes and recommended corrections for technical/statistical review. • Validated structured biomedical elements including subject-level variables, treatment groups, indicators, analysis parameters, and table outputs.