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Responsibilities
- Program and validate SDTM/ADaM datasets supporting a Phase 3 pivotal trial, including longitudinal lab endpoints and averaged-timepoint primary endpoint derivations
- Develop, execute, and QC TFLs; review and validate outputs generated by CRO and vendor partners
- Perform dataset compliance reviews against CDISC standards across active study phases; maintain Define.XML
- Develop data validation programs to support the Data Management team throughout study conduct
- Periodically re-run and verify existing code to ensure ongoing program integrity across multiple related studies
Requirements
- Bachelor’s degree or higher in a quantitative discipline (Statistics, Mathematics, Computer Science, or similar)
- Four or more years of SAS programming in a pharma or CRO setting across Phase I–IV trials; Phase 3 pivotal trial experience required, rare disease or orphan drug exposure a plus
- Proficiency in SDTM, ADaM, and Define.XML; working knowledge of CDISC/CDASH, eCTD, and applicable regulatory guidelines (FDA, ICH, GCP)
- Strong SAS skills across ODS, SQL, Macro, Stat, and Graph; expertise with R a plus
- Comfortable managing competing priorities across multiple active studies in a fast-moving environment