Data Architect – Synthetic Testing Solutions

2 weeks ago

Morādābād, Uttar Pradesh, India beBeeArtificial Full time ₹ 13,76,700 - ₹ 24,47,300

About the Role

We are seeking a Senior Data Scientist 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 Python 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

  • Build Python 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.

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.


Bonus Points:

  • Familiarity with simulation software tools.
  • Understanding of Health Authority regulations.


The Successful Candidate Will Have

  • A degree in computer science, bioinformatics or related field.
  • Experience working with python and machine learning algorithms.
  • Strong understanding of data structures and algorithms.


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