Python AI Engineer – Data Innovator

2 weeks ago

Kannur, Kerala, India beBeeData Full time ₹ 11,24,000 - ₹ 14,59,000

About This Role

As a seasoned Artificial Intelligence Developer, you will play a pivotal role in designing and implementing intelligent frameworks for synthetic test data generation.

This position involves 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:

  • Synthetic Test Data Generation
    • Design and develop 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.
  • AI/ML in Data Generation
    • Apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios.
    • 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 & Data Governance
    • Ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards.
    • Implement anonymization/obfuscation while maintaining clinical and statistical fidelity.
    • Produce validation protocols and documentation for audit and inspection readiness.
  • Collaboration & Integration
    • Work with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements.
    • Embed test data generation into CI/CD pipelines, trial simulations, and automated validation environments.
    • Partner with SMEs to validate AI-generated datasets for regulatory acceptability.

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