Synthetic Data Engineer

1 week ago

Gulbarga, Karnataka, India beBeeDataScientist Full time ₹ 10,00,000 - ₹ 15,00,000
Job Description:

Role Overview

We are seeking an experienced Data Scientist to lead the design and implementation of intelligent frameworks for synthetic and automated test data generation.

Key Responsibilities

  • Synthetic Test Data Automation
    • Develop cutting-edge algorithms to generate realistic clinical and operational datasets.
    • Produce standardized datasets (SDTM, ADaM) for seamless integration with data transformation, analysis, and reporting workflows.
    • Simulate complex datasets (adverse events, labs, demographics, drug exposure) with variability and referential integrity.
    • Design connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
  • AI/ML in Data Generation
    • Apply generative AI (LLMs, GANs, diffusion models) to model intricate clinical scenarios.
    • Create synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems.
    • Utilize AI-driven automation to simulate rare or complex cases for stress and edge-case testing.
  • Compliance & Data Governance
    • Ensure adherence to regulatory standards (GxP, 21 CFR Part 11, HIPAA, GDPR).
    • Implement robust anonymization/obfuscation techniques while maintaining clinical and statistical fidelity.
    • Develop validation protocols and documentation for audit and inspection readiness.
  • Collaboration & Integration
    • Work closely 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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