Experienced I Clin Programmer

Johnson & Johnson; England; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading healthcare company seeks an Experienced Clinical Programmer with expertise in clinical trial programming and data management. You will oversee complex trial activities, develop data models and reporting solutions, and ensure compliance with current standards and regulations. Ideal candidates will possess strong analytical skills and experience in SAS, while contributing to high-quality programming deliverables. This role demands attention to detail and the ability to work collaboratively within a dynamic team environment.

Qualifications

• In-depth knowledge of industry standards and complex data structures.
• Proven technical capabilities in leading clinical trial activities.
• Experience with data model specifications and data stream integrations.

Responsibilities

• Oversee development of clinical data management trial activities.
• Create and execute edit check programs and reports.
• Ensure latest standards and technologies are utilized.

Skills

Advanced Analytics

Analytical Reasoning

Biological Sciences

Biostatistics

Clinical Trials

Data Modeling

Data Privacy Standards

Data Quality

Data Savvy

Detail-Oriented

Good Clinical Practice (GCP)

Report Writing

Research Ethics

Researching

Statistical Analysis Systems (SAS)

Programming

Statistics

Technologically Savvy

Job description

The Experienced Clinical Programmer is an experienced clinical trial programmer with in-depth knowledge in industry standard and complex data structures, programming languages, and/or reporting solutions with proven technical capabilities in leading clinical trial activities and/or teams in accordance with departmental processes and procedures. The position is responsible for oversight or the development of one or more clinical data management trial activities of moderate to high complexity/criticality. Including data model specifications, data stream integrations and transformation of source to internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, listings and report solutions to aid in monitoring of safety, risk, compliance and ensures quality data review. Performs reporting solutions role creating study-specific reports translating clinical study team needs into specifications aggregating clinical data sources into custom data and report to monitor safety, risk and compliance.

• 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.

Preferred Skills:

• Advanced Analytics
• Analytical Reasoning
• Biological Sciences
• Biostatistics
• Clinical Trials
• Data Modeling
• Data Privacy Standards
• Data Quality
• Data Savvy
• Detail-Oriented
• Good Clinical Practice (GCP)
• Report Writing
• Research Ethics
• Researching
• Statistical Analysis Systems (SAS)
• Programming
• Statistics
• Technologically Savvy