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Job Function: Data Analytics & Computational Sciences
Job Sub Function: Biostatistics
Job Category: Scientific/Technology
All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom
Job Description:
The Programmer is an experienced clinical trial programmer with in-depth knowledge in industry standard and complex data structures, programming languages, and reporting solutions. The role requires proven technical capabilities in leading clinical trial activities and teams in accordance with departmental processes and procedures.
The position is responsible for overseeing or developing clinical data management trial activities of moderate to high complexity. Responsibilities include data model specifications, data stream integrations, transformation of source to internal data models, and/or creating CDISC submission-ready SDTM tabulation packages (such as aCRF, define.xml, cSDRG). The programmer creates and executes edit check programs, listings, and report solutions to monitor safety, risk, and compliance, ensuring data quality. They also develop reporting solutions that translate clinical study needs into specifications, aggregating clinical data sources into custom data and reports for monitoring safety, risk, and compliance.
Key responsibilities include:
- Reviewing project requirements and documentation, identifying gaps, proposing solutions, and applying expertise to improve programming efficiency and quality, while ensuring the latest standards and technologies are utilized.
- Creating and reviewing specifications for mapping internal data review models for reporting and submissions, designing algorithms for nonstandard data conversions.
- Developing or reviewing internal data models for reporting and submission packages, staying updated on regulatory requirements, and programming or overseeing quality checks for study-specific reports.
- Aggregating clinical data sources into custom data models for report solutions, performing quality control and verification to support reporting activities.