AI-Powered Data Generation Expert

14 hours ago

Jaipur, Rajasthan, India beBeeDataGeneration Full time ₹ 1,00,00,000 - ₹ 2,50,00,000
Job Opportunity

We are seeking an exceptional Data Generation Specialist

  • Design and develop innovative data frameworks to generate synthetic datasets for clinical and operational purposes.
  • Promote CDISC-compliant dataset generation (SDTM, ADaM) to support transformation, analysis, and reporting workflows.
  • Create domain-specific datasets with variability and referential integrity, catering to the needs of adverse events, labs, demographics, drug exposure, and more.
  • Develop connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows to streamline operations.

Artificial Intelligence in Data Generation

  • Apply advanced AI techniques (LLMs, GANs, diffusion models) to model realistic clinical scenarios.
  • Create comprehensive patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems.
  • Leverage AI-driven automation to simulate rare or complex cases for thorough stress and edge-case testing.

Compliance and Governance

  • Ensure strict adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards.
  • Implement robust anonymization/obfuscation strategies while maintaining clinical and statistical fidelity.
  • Generate validation protocols and documentation for audit and inspection readiness.

Collaboration and Integration

  • Foster collaboration 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 Subject Matter Experts to validate AI-generated datasets for regulatory acceptability.

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