Duke University

School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary

The Clinical Data Management Programmer II works under the supervision of the Clinical Data & Programming Manager and serves as a key technical contributor responsible for developing and maintaining programming solutions that support the Duke Reading Center’s data management infrastructure and operations. This role focuses on programming for clinical trial data integration, quality control, analytics, and custom database builds for electronic data capture, with a strong emphasis on using SAS to automate processes and ensure data integrity. The individual may also serve as a primary clinical data manager on designated clinical studies under the guidance of the Clinical Data & Programming Manager, acting as the main point of contact for study teams and sponsors regarding data handling, cleaning, and provisioning.

Responsibilities

• Design, develop, test, and maintain SAS programs and scripts to automate clinical data integration, cleaning, reshaping, and export processes.
• Build and maintain data pipelines to support the export, transformation, and validation of ophthalmic imaging graded data and functional test data from various sources.
• Develop reusable macros, templates, and code libraries to streamline clinical data workflows and ensure consistency across studies.
• Use SAS and other analytical tools (e.g., R, Python) to build custom reports and visualizations to monitor data quality and support operational decisions.
• Document all data processes and code thoroughly in compliance with GCP and internal documentation standards.
• Serve as the designated clinical data manager on assigned studies, coordinating data activities and acting as the primary point of contact for sponsors and CROs. Lead the development of clinical data management planning documents (including database design specifications, data transfer agreements and other sponsor-facing documentation) in collaboration with project stakeholders for the assigned studies.
• Perform clinical data review, cleaning, discrepancy management, and coding in alignment with study protocols and DRC scope of work.
• Collaborate with study teams to design case report forms (CRFs) and data collection strategies.
• Support the validation and quality control activities of Electronic Grading System (EGS) study databases as needed.
• Contribute to the development and maintenance of SOPs, work instructions, and validation documentation for clinical data management processes and systems.
• Partner with other data programmers and analysts to enhance the Reading Center’s data infrastructure and implement standardized solutions.
• Train and mentor colleagues & end users on SAS, other data management tools, and DM best practices.
• Provide one-on-one and small group instruction to study teams and staff on tools and workflows to strengthen data literacy.
• Participate in internal working groups to drive continuous improvement and innovation in data management practices across the Reading Center.
• Attend and contribute to Reading Center Data Team meetings, staff meetings, and project-specific discussions.
• Communicate effectively with technical and non-technical stakeholders to translate study needs into efficient data solutions.
• Perform other related duties incidental to the work described herein, as assigned by the Clinical Data & Programming Manager.

Required Qualifications

• Bachelor’s degree in a scientific, technical, or health-related field.
• Minimum of 2 years of clinical data management experience.
• Minimum of 2 years of progressive SAS programming experience.
• Demonstrated proficiency in SAS, including data step programming, macros, hash object, and PROC SQL, is a must.
• Familiarity with good clinical data management practices, CDISC standards, and regulatory requirement is a plus.
• Experience with ophthalmology or imaging studies is a plus.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends onthe robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.