Senior Clinical Programmer

Role Summary

The Senior Clinical Programmer role is responsible for performing clinical programming activities as delegated by the Program or Study Lead. The Senior Clinical Programmer role is responsible for executing clinical programming activities for assigned studies. This includes oversight of database builds, oversight of all clinical programming for data transfers, data validation, oversight and creation of system to system integrations and the generation of complete, correct and consistently fit-for-purpose operational datasets for data snapshot and data finalization activities.

The Senior Clinical Programmer will be an individual contributor and will not require any people management. This position will contribute to and make an impact on project or study team outputs.

Responsibilities

• Collaborate with Data Manager to complete Data Validation Plans/Data Review Plans, including the definition of edit checks, data listings, and related analysis to ensure data collected is complete, in conformance with parameters and plausible.
• Review Data Transfer Specifications (DTS) and conduct clinical programming for import of third-party clinical data and related reconciliations.
• Conduct the programming and execution of Level 1 (edit checks by third party developers), Level 2 (clinical data review listings), and Level 3 (statistical data analysis / reviews) validation.
• Conduct Peer Review on Clinical Programming objects, listings, metrics, graphs, and data visualizations.
• Prepare operational, raw data for DB lock or snapshot.
• Export data from EDC and import from external vendor; execute data quality checks; convert to SAS datasets; check for patient ID; ensure review and approval by Global Data Science stakeholders; lock permissions on folders for limited write access.
• Participate in initiatives aimed at expanding Global Data Science and Data Management capability in a designated area of expertise, such as ePRO, Artificial Intelligence (AI), Imaging, Real-World Evidence, etc., by building best practices in processes, tools, templates, or other guidance for the subject area.

Qualifications

• 2+ years’ experience with Master’s, or 5+ years with Bachelor’s degree.
• Relevant clinical development experience inclusive of technical and management experience within and outside of Data Management.

Education

• Degree in Statistics, Computer Science, or Life Sciences.
• Master’s preferred; Bachelors acceptable with relevant experience.