AI Test Data Specialist

7 days ago

Varanasi, Uttar Pradesh, India beBeeData Full time ₹ 9,00,000 - ₹ 12,15,000
Job Title: AI Engineer

We are seeking a skilled Python AI Engineer to design and implement intelligent frameworks for synthetic test data generation.

This role will leverage AI/ML and Python automation to deliver high-quality 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 with variability and referential integrity.
  • Develop connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
  • Apply generative AI 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.
  • Ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards.
  • Implement anonymization while maintaining clinical and statistical fidelity.
  • Produce validation protocols and documentation for audit and inspection readiness.
  • 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.

Required Skills & Qualifications:

  • Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow, etc.).
  • Hands-on experience generating synthetic clinical data or applying CDISC standards.
  • Familiarity with clinical data management systems (e.g., Medidata Rave, Veeva CDB, Oracle InForm).
  • Knowledge of GxP/21 CFR Part 11 and regulated data handling.
  • Experience with test automation frameworks and validation tools.

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