Python AI Engineer

4 days ago

Mangalore, Karnataka, India beBeeDataScience Full time ₹ 50,00,000 - ₹ 84,00,000
Job Description

We are seeking a highly skilled Python AI Engineer to lead the design and implementation of intelligent frameworks for synthetic and automated 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.

The ideal candidate will have strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow, LangChain, etc.) and hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).

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, and 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, and 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, and produce validation protocols and documentation for audit and inspection readiness.
Requirements
  • Strong Python Expertise: pandas, NumPy, scikit-learn, PyTorch/TensorFlow, LangChain, etc.
  • Hands-on Experience: generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML)
  • Familiarity with Clinical Data Management Systems: Medidata Rave, Veeva CDB, Oracle InForm, etc.
  • Knowledge of Regulated Data Handling: GxP/21 CFR Part 11, HIPAA, GDPR, etc.
  • Test Automation Frameworks & Validation Tools: PyTest, Robot Framework, Pinnacle21, etc.
Benefits
  • Opportunity to work on cutting-edge AI/ML projects
  • Chance to collaborate with cross-functional teams
  • Professional growth and development

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