Clinical Data Scientist

2 days ago


Coimbatore, Tamil Nadu, India beBeeAi Full time US$ 1,10,000 - US$ 1,30,000
Job Title:

Clinical Data Scientist - Ai Driven Synthetic Data Generation

About the Role

We are seeking a Clinical Data Scientist to design and implement intelligent frameworks for synthetic test data generation in support of clinical trials, regulatory submissions, and GxP-compliant systems.

This is an exciting opportunity to apply your knowledge of Ai/ML and data science to generate high-quality synthetic clinical datasets. You will work closely with cross-functional teams to develop innovative solutions that meet the needs of our clients.

Main Responsibilities
  • Synthetic Test Data Automation:
    • Build Python frameworks to generate synthetic clinical and operational datasets with variability and referential integrity.
    • Produce CDISC-compliant datasets (SDTM, ADaM) for data transformation, analysis, and reporting workflows.
    • 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.
  • Collaboration & Integration:
    • Work with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to gather requirements.
    • Embed test data generation into CI/CD pipelines, trial simulations, and automated validation environments.
    • Partner with SMEs to validate Ai-generated datasets for regulatory acceptability.
    Required Skills and 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 (Medidata Rave, Veeva CDB, Oracle InForm).
    • Knowledge of GxP/21 CFR Part 11 and regulated data handling.
    • Experience with test automation frameworks (PyTest, Robot Framework) and validation tools (Pinnacle21).
    Preferred Qualifications
    • Background supporting clinical trial systems (EDC, CTMS, PV, LIMS, eCOA).
    • Understanding of statistical workflows (SAS, R) and integration into test pipelines.
    • Cloud experience (AWS, Azure, GCP) for secure Ai/ml deployment.
    • Experience with inspection readiness and validation documentation in pharma.

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