Associate Director, Clinical Data Integration & AI Programming

Role: Associate Director responsible for developing automated clinical data integration pipelines and interactive dashboards to support drug development programs. Responsibilities: design, build, and maintain data ingestion workflows from diverse sources (EDC, labs, eCOA, IRT), establish standardized data models, implement quality and congruency checks, and develop APIs for data access. Create and validate R/Shiny and Python dashboards for clinical review, study monitoring, and operational metrics; develop reusable code components; and automate study team communications. Lead technical standards, validation, and platform management, including GxP compliance, validation, and deployment within enterprise Posit/RStudio environments. Evaluate and incorporate AI and generative AI tools to improve data processing, quality review, and programming efficiency, ensuring human oversight and regulation adherence. Oversee technical and process improvements, vendor and CRO oversight, and partner with cross-functional teams for requirement gathering and adoption. Provide training and mentorship on R, Python, data automation, and responsible AI. Qualifications: Bachelor’s in statistics, biostatistics, computer science, data science, or related field; 10+ years in clinical programming, data engineering, or analytics in pharma/biotech; advanced R (Shiny, tidyverse, R Markdown), Python, SQL, and API experience; expertise in clinical data standards (SDTM, ADaM), GxP, and regulatory compliance; experience with Posit tools and AI integration; strong stakeholder communication skills; willingness to travel. High-value specifics: focus on clinical trial data automation, cross-study data harmonization, AI-enabled tools, and enterprise R/Python platforms. Work setup: not specified, travel required.