Python AI Specialist

18 hours ago

Jodhpur, Rajasthan, India beBeeArtificialIntelligence Full time ₹ 1,50,00,000 - ₹ 2,10,00,000

Job Summary:

About the Role

We are seeking a Python AI Engineer to design and implement intelligent frameworks for synthetic data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

This role will leverage AI/ML and automation to deliver high-quality datasets that reduce reliance on production data, accelerate testing cycles, and ensure compliance with FDA, EMA, and global standards.

Key Responsibilities:
  • 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 with variability and referential integrity.
  • Develop connectors for Define-XML, validation, and statistical programming workflows.
AI/ML Applications in Data Generation:
  • Apply generative AI (LLMs, GANs, diffusion models) to model realistic clinical scenarios.
  • Create synthetic patient journeys across various systems.
  • Use AI-driven automation to simulate rare or complex cases.
Compliance & Governance:
  • Ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards.
  • Implement anonymization/obfuscation while maintaining clinical fidelity.
  • Produce validation protocols and documentation for audit readiness.
Collaboration & Integration:
  • Work with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams.
  • Embed data generation into CI/CD pipelines and automated validation environments.
  • Partner with SMEs to validate datasets for regulatory acceptability.
Required Skills:
  • Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow).
  • Hands-on experience generating synthetic clinical data or applying CDISC standards.
  • Familiarity with clinical data management systems.
  • Knowledge of GxP/regulated data handling.
  • Experience with test automation frameworks and validation tools.
Preferred Qualifications:
  • Background supporting clinical trial systems.
  • Understanding of statistical workflows and integration into test pipelines.
  • Cloud experience for secure AI/ML deployment.
  • Experience with inspection readiness and validation documentation.

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