Note: The job is a remote job and is open to candidates in USA. Cook Research Inc. is a global, family-owned company committed to improving patients' lives since 1963. They are seeking a Senior Clinical Data Scientist responsible for applying advanced analytics and AI methodologies to generate actionable insights and predictive capabilities in clinical data. The role involves partnering with cross-functional stakeholders to translate complex problems into analytical strategies and ensuring data integrity and safety in clinical trials.
Responsibilities
- Develop and deploy advanced analytical models, including machine learning, predictive modeling, forecasting, and anomaly detection
- Apply AI/ML techniques to solve complex business problems and identify patterns, risks, and opportunities within large, multi-source datasets
- Design, build, and maintain scalable analytical solutions and reusable data science frameworks
- Translate analytical findings into clear, accurate, and actionable insights tailored for technical and non-technical stakeholders
- Partner with cross functional teams to ensure insights are actionable and aligned to business priorities
- Contribute to the development of KPIs, metrics, and performance measurement frameworks in collaboration with cross-functional stakeholders
- Mentor peers and contribute to building data science and AI/ML capabilities across the organization
- Apply advanced analytics to patient-level, site-level, and study-level clinical data, processes, and documents to support study design and strategy, execution, oversight, and portfolio insights including potential claims
- Integrate and analyze data across clinical systems (e.g., EDC, CTMS, eTMF, safety systems, external data sources) to provide a holistic view of site and study performance and data reliability
- Evaluate data quality, data risk, and data completeness in the context of clinical trial conduct, identifying potential impacts to patient safety and endpoint integrity
- Ensure analytical approaches align with regulatory authority expectations for electronic records (e.g., data integrity, traceability, reproducibility) and the use of AI in generating outputs
- Apply knowledge of Good Clinical Data Management Practices (GCDMP), and regulatory authority expectations to ensure data is not only complete, but credible and fit for decision-making
- Support inspection readiness through well-documented processes and auditable analytical outputs
Skills
- Bachelor's degree (Masters or PhD preferred) in Data Science, Biostatistics, Statistics, Computer Science, Biomedical Engineering, or a related quantitative discipline; or equivalent combination of education and experience
- Minimum 5–8 years of relevant experience in data science, advanced analytics, or AI/ML
- Demonstrated experience working with complex, multi-source datasets in regulated environments
- Strong proficiency in analytical programming languages and tools (e.g., Python, R, SQL)
- Experience developing analytical models and data visualization tools (e.g., Power BI)
- Experience developing and deploying machine learning models
- Familiarity with data engineering concepts and working with large datasets
- Strong problem-solving and analytical thinking skills
- Ability to work in ambiguous environments and define analytical approaches
- Strong communication skills with the ability to translate technical findings into business insights
- Collaborative mindset with experience working in cross-functional teams
- Comfortable working with ambiguous questions and incomplete data while clearly articulating assumptions and limitations
- Capable of acquiring and maintaining Cook Mastery Level of Artificial Intelligence competency, including the ability to assess feasibility and risk of AI use cases, design or coordinate workflow-level AI solutions, guide teams on responsible AI governance, mentor others, and contribute to organizational policies and ethical decision-making
- Qualified candidates must be legally authorized in the United States
- Experience working with patient-level clinical data, clinical operations data, CMS/claims data, or other regulated healthcare datasets strongly preferred
- Working knowledge of clinical research systems, and data and documentation management structures (e.g., EDC, CTMS, eTMF, CDISC, CDASH)
- Understanding of clinical study execution, oversight, and operational workflows within a regulated environment
Benefits
- Competitive, performance-related compensation and benefits that support your health and financial wellbeing.
- Paid time off, holidays, and hybrid or remote work options for many jobs, where possible.
- Learning opportunities, educational assistance, and development programs to help you grow your skills and career.
- Health and wellness initiatives, social activities, and community engagement that help you feel connected and supported.
Company Overview
Cook Medical is a medical device company that specializes in designing, manufacturing, and delivering invasive medical devices. It is a sub-organization of Cook Group. It was founded in 1963, and is headquartered in Bloomington, Indiana, USA, with a workforce of 10001+ employees. Its website is http://www.cookmedical.com.