Johnson & Johnson Innovative Medicine
Experienced I Clin Programmer
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Experienced I Clin Programmer
At Johnson & Johnson
We believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognise their merit.
Job Details
- Job Function: Data Analytics & Computational Sciences
- Job Sub Function: Biostatistics
- Job Category: Scientific/Technology
- Locations: High Wycombe, Buckinghamshire, United Kingdom
Position Summary
The Experienced Clinical Programmer is an experienced professional in clinical trial programming with in-depth knowledge of industry-standard and complex data structures, programming languages, and reporting solutions. They must demonstrate proven technical capabilities in leading clinical trial activities and/or teams, ensuring adherence to departmental processes and procedures.
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The role involves oversight or development of one or more clinical data management trial activities of moderate to high complexity/criticality. This includes:
- Creating or overseeing data model specifications
- Managing data stream integrations and transformations of source to internal data models as well as CDISC submission-ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc.)
- Developing and executing edit check programs, listings, and reporting solutions to aid in monitoring safety, risk, compliance, and ensuring quality data reviews.
A secondary focus is to support the creation of study-specific reports, translating clinical study requirements into specifications while aggregating clinical data sources into custom data and reports for safety, risk, and compliance monitoring.
Role & Responsibilities
- Oversee or perform one or more clinical programming trial activities of moderate to high complexity, scope, or criticality.
- Conduct a comprehensive review of, and provide input into, project requirements and documentation. Identify gaps, propose solutions, and apply expertise to improve efficiency of programming tasks and/or enhance overall quality of programming deliverables.
- Ensure the latest standards are utilised, and current technologies are deployed.
- Create or review specifications for mapping internal data review models for fit-for-purpose reporting and/or submission-ready CDISC SDTM. Design mapping algorithms for non-standard conversions.
- Develop or review internal data models for fit-for-purpose reporting consumption and/or submission-ready CDISC SDTM packages for regulatory submissions, staying current with regulatory requirements.
- Program or oversee quality review checks, developing study-specific reports for team members and data consumers.
- May aggregate clinical data sources into custom data models for study-specific consumption, and develop report solutions while performing appropriate quality control and verification for reporting activities.
- Support or lead initiatives to develop and implement process, system, and tool improvements while remaining compliant with departmental procedures.
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Required Skills
(Precision skills required for success)
Preferred Skills
- Advanced Analytics
- Analytical Reasoning
- Biological Sciences
- Biostatistics
- Clinical Trials
- Data Modeling
- Data Privacy Standards
- Data Quality
- Detail-Oriented
- Good Clinical Practice (GCP)
- Report Writing
- Research Ethics
- Researching
- Statistical Analysis Systems (SAS) Programming
- Statistics
- Technologically Savvy
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