Data Science Lead

2 weeks ago

Anand, Gujarat, India beBeeArtificial Full time ₹ 19,21,049 - ₹ 24,26,478

Job Title:

We are seeking an Artificial Intelligence Engineer to design and implement intelligent frameworks for synthetic test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

Key Responsibilities:

  • Synthetic Test Data Automation
    • Create software 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.
  • Ai/ml in Data Generation
    • Apply generative AI models to simulate 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 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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