AI Data Specialist

22 hours ago

Surat, Gujarat, India beBeeAi Full time ₹ 20,00,000 - ₹ 25,00,000

Job Description

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We are seeking a highly skilled AI Data Specialist to join our team and design innovative frameworks for synthetic test data generation. This role will leverage artificial intelligence and machine learning expertise to deliver high-quality, compliant datasets that accelerate testing cycles and reduce reliance on production data.

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Key Responsibilities:

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  • Develop 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.">
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Artificial Intelligence in Data Generation:

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  • Apply generative AI techniques (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.">
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Compliance & Data Governance:

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  • 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.">
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Collaboration & Integration:

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  • 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.">
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Required Skills & Qualifications:

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  • Strong Python expertise (pandas, NumPy, scikit-learn, PyTorch/TensorFlow).">
  • 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).">
  • Hands-on experience generating synthetic clinical data or applying CDISC standards (SDTM, ADaM, Define-XML).">
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Preferred Qualifications:

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  • 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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