Data Scientist

2 days ago

Belgaum, Karnataka, India beBeeDataScientist Full time ₹ 15,00,000 - ₹ 25,00,000

Data Scientist - Synthetic Data Generation

We are seeking a highly skilled Data Scientist 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 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

  • Develop Python frameworks to generate synthetic clinical and operational datasets.
  • Produce CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
  • Simplify 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

  • Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow).
  • Hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).
  • Familiarity with clinical data management systems.
  • Knowledge of GxP/21 CFR Part 11 and 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.

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