AI System Developer

23 hours ago

Vijayawada, Andhra Pradesh, India beBeeAI Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: AI Software Engineer

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We are seeking an expert in AI software engineering to create intelligent systems for synthetic and automated test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

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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.

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The ideal candidate will have strong expertise in Python programming, experience generating synthetic clinical data, and knowledge of CDISC standards. Familiarity with clinical data management systems, GxP regulations, and test automation frameworks is also highly desirable.

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Key Responsibilities:

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  • Design and implement Python frameworks for synthetic test data generation.
  • Produce CDISC-compliant datasets for data transformation, analysis, and reporting workflows.
  • Develop connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows.
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Ambitions:

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  • Apply generative AI 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.
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Deliverables:

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  • 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.
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Skills and Qualifications:

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  • Strong Python programming skills.
  • Experience generating synthetic clinical data or applying CDISC standards.
  • Familiarity with clinical data management systems.
  • Knowledge of GxP/21 CFR Part 11 and regulated data handling.
  • Experience with test automation frameworks.

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