Experienced Clinical Programmer

Johnson & Johnson; High Wycombe; On-site; GBP 65,000 - 90,000; Full time

Job summary

Johnson & Johnson in the United Kingdom seeks an Experienced Clinical Programmer to lead data management and SDTM submission activities for complex trials. You will develop data models, mappings, and edit checks to support safety, risk, and compliance.

The role requires SAS programming and CDISC SDTM knowledge, with collaboration across cross-functional teams to ensure high-quality data and regulatory readiness.

Qualifications

• Experience in clinical trial programming and data management.
• Experience with SDTM and CDISC submission packages.
• Strong SAS programming skills.
• Ability to translate study requirements into data specifications.

Responsibilities

• Oversee one or more programming activities of moderate to high complexity.
• Review project requirements and identify gaps, propose solutions.
• Ensure latest standards and technologies are used.
• Create specifications for data mapping and submission-ready SDTM packages.
• Lead quality checks and study-specific reports for stakeholders.

Skills

SAS Programming

CDISC SDTM

Data Modeling

Clinical Trial Data Management

Regulatory Compliance

Job description

Position Summary

The Experienced Clinical Programmer is an experienced clinical trial programmer with 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 the development of one or more clinical data management trial activities of 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 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 and report to monitor safety,, risk and compliance.

Role and 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 project requirements and documentation. Identifies gaps, proposes solutions and 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.

Required Skills

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

Johnson & Johnson is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.