At a Glance
- Tasks: Lead clinical programming activities and ensure quality data management for clinical trials.
- Company: Join a leading organisation in biostatistics and data analytics.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and compliance.
- Why this job: Make a real impact in clinical research and improve patient outcomes.
- Qualifications: Experience in clinical programming and strong analytical skills required.
The predicted salary is between 50000 - 65000 £ per year.
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.
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 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.
Required 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
Experienced I Clin Programmer in High Wycombe employer: 7360-Janssen-Cilag Limited Legal Entity
Janssen-Cilag Limited is an exceptional employer that fosters a collaborative and innovative work culture in High Wycombe, England. With a strong commitment to employee development, we offer extensive growth opportunities through mentorship and training, ensuring our team members thrive in their careers while contributing to impactful clinical programming strategies. Our focus on operational excellence and compliance not only enhances the quality of our work but also creates a rewarding environment for those passionate about advancing healthcare.
Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team
