Job Description

Job Description Insight Global is seeking a Senior Data Scientist with 8-10 years of experience in the biomed/biotech or healthcare industry (excluding IT), to lead the design, development, and deployment of AI and machine learning models for early drug discovery and clinical data analysis. The role focuses on supporting medical device (Class II/III) and combination product development, leveraging ML to extract insights from clinical trial data (Phase 1-3) and drug molecule research. Key Responsibilities: - Model Development & Validation: o Develop and optimize ML algorithms for predictive modeling, imaging, biomarker discovery, and patient stratification. o Apply deep learning to imaging, omics, and real-world evidence datasets. - Data Engineering & Integration: o Architect scalable pipelines for structured and unstructured biomedical data. o Harmonize data from clinical, regulatory, and laboratory sources using semantic modeling. - Domain-Specific Analytics: o Analyze, interpret, and synthesize biological and clinical data using statistical and computational methods. - Cross-Functional Collaboration: o Communicate across matrixed teams (leadership, clinicians, regulatory strategists, QA, software engineers). o Support dashboard design and visual analytics for compliance platforms. - Ethical AI & Governance: o Implement bias detection, explainability, and validation protocols for regulated environments. o Support audit-readiness and documentation for AI/ML systems in GxP contexts. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: Skills and Requirements Qualifications: - MSc or PhD in Data Science, Bioinformatics, Computational Biology, or related field (industry experience not required for advanced degrees). - 8-10 years total experience in biomed/biotech or healthcare (not IT). - Advanced proficiency in Python, R, SQL, and ML libraries (scikit-learn, TensorFlow, PyTorch). - Extensive background in statistics, bioinformatics, and computational biology supporting medical device technologies. - Experience with data handling and documentation supporting regulatory compliance (FDA, EMA, MHRA, TGA, etc.). - Knowledge of consensus standards (AAMI, CISA, ICH, IMDRF, ISO, NIST), compliance automation, cybersecurity, and data privacy protection. - In-depth understanding of semantic graph schemas, ontology-driven modeling, and modular UI/UX design.

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