Advanced AI Developer

2 weeks ago

Erode, Tamil Nadu, India beBeeData Full time US$ 1,04,170 - US$ 1,41,930

Job Opportunity:

We are seeking a Python AI Engineer to design and implement 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.

Key Responsibilities:

Synthetic Test Data Automation

  • Develop and 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.

Required Skills & Qualifications:

Technical Expertise

  • Pandas, NumPy, scikit-learn, PyTorch/TensorFlow, LangChain, etc.

Data Generation Experience

  • CDISC standards (SDTM, ADaM, Define-XML)

Clinical Data Management Systems

  • Medidata Rave, Veeva CDB, Oracle InForm, etc.

GxP Compliance Knowledge

  • Regulated data handling

Test Automation Frameworks

  • PyTest, Robot Framework

Validation Tools

  • Pinnacle21

Preferred Qualifications:

Background Supporting Clinical Trial Systems

  • EDC, CTMS, PV, LIMS, eCOA

Statistical Workflow Understanding

  • SAS, R

Cloud Experience

  • AWS, Azure, GCP

Inspection Readiness Experience

  • Validation documentation in pharma
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