Senior Clinical Programmer - SDTM & Data Reporting

Johnson & Johnson Co.; High Wycombe; On-site; GBP 60,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking an Experienced Clinical Programmer to lead and oversee clinical data management activities. The role covers data modeling, SDTM packaging for health authority submissions, and development of study-specific reports to monitor safety and compliance.

The position requires deep knowledge of data structures, programming languages, and reporting solutions, with a track record of delivering high-quality programming deliverables within departmental processes.

Responsibilities

• Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality.
• Performs comprehensive review of, and provides input into, project requirements and documentation. Identifies gaps, proposes solutions and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables.
• Ensures latest standards are being utilized, current technologies are deployed.
• Create and/or review specifications for mapping internal data review model for fit for purpose reporting and/or as well as submission ready CDISC SDTM. Design mapping algorithms for nonstandard conversions.
• Responsible for creation or review of internal data model for fit for purpose reporting consumption and/or submission ready CDISC SDTM packages for health authority submissions and keeping abreast in changing regulatory requirements. Program, or oversight of quality review checks, study specific reports for use by team members and consumers of data.
• May perform role that programmatically aggregates clinical data sources into custom data model for fit for purpose consumption study specific report solutions performing appropriate quality control and verification in support of assigned reporting activities.
• Support and/or lead in developing and implementing process, system and tool improvement initiatives within compliance with departmental processes and procedures.

Skills

Advanced Analytics

Analytical Reasoning

Biological Sciences

Biostatistics

Clinical Trials

Data Modeling

Data Privacy Standards

Data Quality

Data Savvy

Detail-Oriented

GCP

Report Writing

Research Ethics

Researching

SAS Programming

Statistics

Technologically Savvy

Job description

Johnson & Johnson is seeking an Experienced Clinical Programmer to lead and oversee clinical data management activities. The role covers data modeling, SDTM packaging for health authority submissions, and development of study-specific reports to monitor safety and compliance.

The position requires deep knowledge of data structures, programming languages, and reporting solutions, with a track record of delivering high-quality programming deliverables within departmental processes.