Experienced Clin Programmer

at  Johnson Johnson

Johnson & Johnson are currently seeking an Experienced Clinical Programmer, Clinical Programming to join our Integrated Data Analytics & Reporting (IDAR) Department. This position is based in High Wycombe (Hybrid). Remote work options in the UK may be considered on a case-by-case basis and if approved by the company.
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 https:// www.jnj.com/.
Position Summary
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.
May perform 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.

QUALIFICATIONS

Requirements

• Bachelor’s degree or higher and/or equivalent in computer science, data science/data engineering, mathematics or another relevant scientific field (or equivalent theoretical/technical depth).
• Approximately 4-6+ years of clinical programming/clinical data management experience with increasing responsibility, preferably in the pharmaceutical/clinical trial environment.
• In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
• In-depth CDISC SDTM knowledge.
• Experience working in a team environment.
• Demonstrated written and verbal communications skills.
• Basic knowledge of regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong

• 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