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3 days ago
We are seeking a talented Python AI Engineer to join our organization and contribute to the development of intelligent frameworks for synthetic test data generation.
This role will involve leveraging AI/ML and Python automation to deliver high-quality, audit-ready datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global regulatory standards.
Key Responsibilities- Build Python frameworks to generate synthetic clinical and operational datasets.
- Produce CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
- Simulate domain-specific datasets (adverse events, labs, demographics, drug exposure) with variability and referential integrity.
- Develop connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
- Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow).
- Hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).
- Familiarity with clinical data management systems (Medidata Rave, Veeva CDB, Oracle InForm).
- Knowledge of GxP/21 CFR Part 11 and regulated data handling.
- Background supporting clinical trial systems (EDC, CTMS, PV, LIMS, eCOA).
- Understanding of statistical workflows (SAS, R) and integration into test pipelines.
- Cloud experience (AWS, Azure, GCP) for secure AI/ML deployment.
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