AI Data Generation Specialist

1 week ago

Rajkot, Gujarat, India beBeeDataGeneration Full time US$ 80,000 - US$ 1,40,000

Job Summary:

We are seeking a skilled AI Data Generation Specialist to join our team. In this role, you will design and implement intelligent frameworks for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

Key Responsibilities:

  • Synthetic Test Data Automation:
  • You will build Python frameworks to generate synthetic clinical and operational datasets, producing CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
  • Your tasks will include simulating domain-specific datasets (adverse events, labs, demographics, drug exposure) with variability and referential integrity, as well as developing connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
  • AI/ML in Data Generation:
  • You will apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios, creating synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems.
  • Your responsibilities will also include using AI-driven automation to simulate rare or complex cases for stress and edge-case testing.
  • Compliance & Data Governance:
  • You will ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards, implementing anonymization/obfuscation while maintaining clinical and statistical fidelity.
  • Your tasks will include producing validation protocols and documentation for audit and inspection readiness.
  • Collaboration & Integration:
  • You will work with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements, embedding test data generation into CI/CD pipelines, trial simulations, and automated validation environments.
  • Your responsibilities will also include partnering with SMEs to validate AI-generated datasets for regulatory acceptability.

About the Role:

This is an exciting opportunity to leverage your expertise in AI and data generation to drive innovation in clinical trials and regulatory submissions. If you are passionate about harnessing the power of AI to improve healthcare outcomes, we encourage you to apply.

What We Offer:

  • A dynamic and supportive work environment
  • Ongoing training and professional development opportunities
  • The chance to work on cutting-edge projects that make a real difference in people's lives

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