
AI Data Generation Specialist
22 hours ago
Job Title: AI Data Generation Specialist
About the RoleWe are seeking an experienced professional to join our team as a Python AI Engineer focused on designing and implementing intelligent frameworks for synthetic test data generation. The ideal candidate will have expertise in building automated test data solutions using Python, with a strong background in generative AI, machine learning, and statistical programming.
Main Responsibilities- Synthetic Test Data Automation:
- Create high-quality synthetic datasets using Python frameworks that mimic real-world clinical scenarios.
- Develop connectors for integration with existing workflows, including Define-XML, Pinnacle21 validation, and statistical programming tools.
- Foster collaboration with Clinical Data Management, Biostatistics, Pharmacovigilance, and Compliance teams to ensure seamless integration of test data generation into clinical trials and regulatory submissions.
- AI/ML in Data Generation:
- Apply advanced AI techniques, such as generative adversarial networks (GANs) and diffusion models, to create realistic 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, ensuring compliance with regulatory standards.
- Partner with subject matter experts (SMEs) to validate AI-generated datasets for regulatory acceptability.
- Compliance & Data Governance:
- Ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR standards for secure and compliant data handling.
- Implement anonymization and obfuscation techniques while maintaining clinical and statistical fidelity.
- Develop and maintain validation protocols and documentation for audit and inspection readiness.
- Education & Qualifications
- Bachelor's degree in Computer Science, Mathematics, Statistics, or related field.
- Minimum 5 years of experience in software development, machine learning, and/or statistical programming.
- Proven track record of delivering high-quality results under tight deadlines.
- Required Skills & Tools:
- Proficiency in Python, R, or other programming languages.
- Experience with machine learning frameworks, such as TensorFlow or PyTorch.
- Familiarity with statistical programming languages, such as SAS or SQL.
- Knowledge of cloud-based platforms, such as AWS or Azure.
- Excellent problem-solving skills and attention to detail.
- Strong communication and collaboration skills.
- Benefits & Perks:
- Career growth opportunities within a dynamic and innovative company.
- Competitive salary and benefits package.
- Opportunities for professional development and training.
How to Apply: If you are a motivated and detail-oriented individual with a passion for AI and data generation, please submit your application, including your resume and a cover letter outlining your qualifications and experience.
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