Senior Clinical Programmer: SDTM & Data Reporting Expert

Johnson & Johnson Innovation; High Wycombe; On-site; GBP 60,000 - 100,000; Full time

Job summary

Johnson & Johnson Innovation is seeking an Experienced Clinical Programmer to lead complex clinical data tasks and support SDTM submissions. You will oversee data management activities, create edit checks, and develop study-specific reports to monitor safety and compliance.

The role requires deep knowledge of data structures, programming languages, and reporting solutions within regulatory guidelines, collaborating with cross-functional teams.

Qualifications

• Must have experience as an Experienced Clinical Programmer in clinical trials.
• Knowledge of CDISC SDTM, aCRF, define.xml and related data standards.
• Ability to design mapping algorithms for nonstandard conversions.
• Experience with data modeling, data integration, and data quality checks.

Responsibilities

• Accountable for one or more clinical programming trial activities of moderate to high complexity.
• Review project requirements, identify gaps, and propose solutions to improve efficiency and quality.
• Ensure latest standards and current technologies are deployed.
• Create or review specifications for data mapping and SDTM submission packages.
• Program or oversee quality checks and study-specific reports for safety and compliance.
• Aggregate clinical data sources into fit-for-purpose reporting and data models.
• Support process and tool improvements within compliance.

Job description

Johnson & Johnson Innovation is seeking an Experienced Clinical Programmer to lead complex clinical data tasks and support SDTM submissions. You will oversee data management activities, create edit checks, and develop study-specific reports to monitor safety and compliance.

The role requires deep knowledge of data structures, programming languages, and reporting solutions within regulatory guidelines, collaborating with cross-functional teams.