Artificial Intelligence Driven Test Data Generation Expert

4 days ago

Cochin, Kerala, India beBeeIntelligent Full time ₹ 18,00,000 - ₹ 25,00,000

Job Title: Intelligent Test Data Generation Specialist

About the Role

We are seeking a skilled specialist to design and implement intelligent frameworks for synthetic test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems. This role will leverage AI/ML and 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 Automation

  • Develop 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.

Required Skills & Qualifications

  • Strong python expertise (pandas, numpy, scikit-learn, pytorch/tensorflow, langchain, 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).

Preferred Qualifications

  • 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.
  • Experience with inspection readiness and validation documentation in pharma.

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