Summary/Job Purpose
- Develop, train, and validate AI/ML models and analytics solutions that transform clinical datasets into analysis-ready deliverables supporting drug-development decisions in a GxP-governed pipeline.
Essential Duties/Responsibilities
- Build, train, and validate supervised/unsupervised ML models to predefined acceptance criteria.
- Clean, transform, and standardize clinical data from EDC, vendor, and real-world sources aligned to CDISC (SDTM/ADaM).
- Develop and maintain LLM/generative AI workflows for automated TLF review and ad-hoc queries with human-in-the-loop validation.
- Create interactive dashboards/visualizations for clinical review and decision-making.
- Perform data validation/quality assurance to ensure accuracy, reproducibility, and GxP compliance.
- Support Databricks/AWS pipeline development using Git/GitHub version control and CI/CD.
- Collaborate with Statistical Programming, Clinical Data Management, and Clinical Operations; maintain SOP-consistent documentation.
Education/Experience
- BS (7+ years) or MS (5+ years) in a quantitative field, or equivalent.
- PhD: no prior structured/unstructured AI/ML required; MS: 1+ year; BS: 3+ years; no degree: 7+ years.