Associate Director, Clinical Data Integration & AI Programming
New
J
JobgetherPharmaceutical and biotechnology
This is a remote U.S. opportunityFull-TimeDirector
SalaryAnnual base salary range of $158,000–$197,900 USD.
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Job Details
- Experience
- Approximately 10 years of progressively responsible experience in statistical programming, clinical programming, clinical data engineering, or clinical analytics
- Required Skills
- PythonSQLGitRESTful APIsR
Requirements
- Bachelor’s degree in statistics, biostatistics, computer science, data science, biomedical informatics, or a related scientific discipline; equivalent education and relevant experience may be considered.
- Approximately 10 years of progressively responsible experience in statistical programming, clinical programming, clinical data engineering, or clinical analytics.
- Experience delivering technical solutions across multiple clinical studies or programs.
- Advanced R programming, including Shiny, tidyverse, data.table, R Markdown/Quarto, package development, modular application design, and reproducible workflows.
- Strong Python skills for data ingestion, transformation, automation, analytics, and application development.
- Strong SQL proficiency and experience developing and consuming REST APIs.
- Experience building and deploying clinical dashboards, patient profiles, data review tools, or study monitoring applications.
- Experience designing automated clinical data ingestion, transformation, mapping, validation, and refresh processes.
- Experience with Posit/RStudio Workbench, Posit Connect, and Posit Package Manager, or comparable enterprise environments.
- Experience with Git, automated testing, CI/CD, logging, monitoring, and controlled software deployment.
- Knowledge of clinical trial data and CDISC standards, including SDTM, ADaM, metadata-driven programming, and integrated data structures.
- Working knowledge of SAS and ability to bridge SAS workflows with R and Python solutions.
- Practical understanding of generative AI, LLMs, RAG, and AI-assisted programming in regulated environments.
- Knowledge of GCP, ICH, 21 CFR Part 11, data privacy, access controls, audit trails, and validation expectations.
- Willingness and ability to travel domestically and internationally as needed.
Responsibilities
- Design and maintain automated pipelines ingesting clinical data from EDC, laboratory, eCOA, IRT, safety, and other external sources.
- Own standardized cross-study clinical data models and metadata-driven mapping specifications.
- Develop automated data quality checks and reconciliation workflows, routing actionable exceptions to study teams.
- Build governed APIs and data-access components for dashboards and downstream programming.
- Develop, validate, deploy, and maintain interactive R/Shiny and Python dashboards and clinical review tools.
- Create reusable R and Python packages, modules, visualization components, templates, and metric definitions.
- Establish and operationalize enterprise R/Posit capabilities and governed deployment practices.
- Define and enforce development standards for code review, testing, logging, Git, and CI/CD.
- Evaluate and implement governed AI and generative AI capabilities with human review and validation.
- Oversee vendor and consultant deliverables, mentor programmers, and guide the clinical data automation roadmap.
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