Experienced I Clin Programmer

Johnson & Johnson Innovation; High Wycombe; On-site; GBP 60,000 - 100,000; Full time

Job summary

Johnson & Johnson Innovation is seeking an Experienced Clinical Programmer to lead complex clinical data tasks and support SDTM submissions. You will oversee data management activities, create edit checks, and develop study-specific reports to monitor safety and compliance.

The role requires deep knowledge of data structures, programming languages, and reporting solutions within regulatory guidelines, collaborating with cross-functional teams.

Qualifications

• Must have experience as an Experienced Clinical Programmer in clinical trials.
• Knowledge of CDISC SDTM, aCRF, define.xml and related data standards.
• Ability to design mapping algorithms for nonstandard conversions.
• Experience with data modeling, data integration, and data quality checks.

Responsibilities

• Accountable for one or more clinical programming trial activities of moderate to high complexity.
• Review project requirements, identify gaps, and propose solutions to improve efficiency and quality.
• Ensure latest standards and current technologies are deployed.
• Create or review specifications for data mapping and SDTM submission packages.
• Program or oversee quality checks and study-specific reports for safety and compliance.
• Aggregate clinical data sources into fit-for-purpose reporting and data models.
• Support process and tool improvements within compliance.

Job description

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 recognize their merit.

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Biostatistics

Job Category:

Scientific/Technology

All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

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.

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.

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