Synthetic Test Data Specialist

1 week ago

Allahabad, Uttar Pradesh, India beBeeData Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

As a skilled Python AI Engineer, you will be responsible for designing and implementing intelligent frameworks for synthetic test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

Key Responsibilities:
  • Create high-quality, synthetic datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global regulatory standards.
  • Develop CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows that meet the highest standards of quality and accuracy.
  • Simulate domain-specific datasets with variability and referential integrity, ensuring the highest level of realism and authenticity.
AI/ML in Data Generation:
  • Apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios, enabling the creation of high-quality, synthetic patient journeys.
  • Create synthetic patient journeys across EDC, eCOA, CTMS, LIMS, and PV systems, streamlining testing and validation processes.
  • Use AI-driven automation to simulate rare or complex cases for stress and edge-case testing, ensuring the highest level of preparedness and compliance.
Compliance & Data Governance:
  • Evaluate and adhere to GxP, 21 CFR Part 11, HIPAA, and GDPR standards, maintaining the highest level of security and confidentiality.
  • Implement anonymization/obfuscation while maintaining clinical and statistical fidelity, ensuring the protection of sensitive information.
  • Develop validation protocols and documentation for audit and inspection readiness, demonstrating transparency and accountability.
Required Skills & Qualifications:
  • Possess strong Python expertise, including proficiency in pandas, NumPy, scikit-learn, PyTorch/TensorFlow, and relevant libraries.
  • Harness hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).
  • Demonstrate familiarity with clinical data management systems.
  • Display knowledge of GxP/21 CFR Part 11 and regulated data handling.
  • Show experience with test automation frameworks and validation tools.

Benefits

This role offers an opportunity to develop cutting-edge skills in AI-driven data generation and contribute to the advancement of clinical trials and regulatory submissions.

The ideal candidate will have a strong foundation in Python programming, experience with CDISC standards, and a passion for innovative data solutions.

We encourage applicants with a background in computer science, data engineering, or a related field to apply.

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