AI Engineer for Synthetic Data Generation

2 days ago

Kanpur, Uttar Pradesh, India beBeeData Full time US$ 70,000 - US$ 1,20,000

Job Title: Python AI Engineer for Clinical Data Generation

Description: We are seeking a skilled Python AI Engineer to join our team in designing and implementing intelligent frameworks for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

Key Responsibilities:

  • Create Python frameworks to generate synthetic clinical and operational datasets with high-quality, audit-ready outputs.
  • Develop CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
  • Synthesize domain-specific datasets (adverse events, labs, demographics, drug exposure) with variability and referential integrity.
  • Build connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.

AI/ML Applications:

  • Apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios and create synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems.
  • Use AI-driven automation to simulate rare or complex cases for stress and edge-case testing.

Compliance and Governance:

  • E nsure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards for data handling and storage.
  • Implement anonymization/obfuscation techniques while maintaining clinical and statistical fidelity.
  • Produce validation protocols and documentation for audit and inspection readiness.

Required Skills and Qualifications:

  • Strong expertise in Python programming language (pandas, NumPy, scikit-learn, PyTorch/TensorFlow, etc.).
  • 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, etc.).
  • Knowledge of GxP/21 CFR Part 11 and regulated data handling.
  • Experience with test automation frameworks (PyTest, Robot Framework) and validation tools (Pinnacle21).

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