Experienced I Clin Programmer

Reposted 6 Hours Ago
Be an Early Applicant
High Wycombe, Buckinghamshire, England, GBR
In-Office
Mid level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Develops and reviews clinical trial programming deliverables including CDISC SDTM submission packages, data model specifications, mappings, edit checks, listings and study-specific reports. Aggregates and transforms clinical data sources, performs quality control and verification, and supports process, system and tool improvements to ensure compliance and fit-for-purpose reporting to monitor safety, risk and regulatory requirements.
Summary Generated by Built In

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. 



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

Skills Required

  • Clinical trial programming experience (moderate to high complexity)
  • CDISC SDTM mapping and creation of submission-ready packages (SDTM, define.xml, cSDRG)
  • Data modeling and data stream integration, mapping algorithms for nonstandard conversions
  • Creation and review of edit checks, listings, and study-specific reports
  • Quality control, verification and review of programming deliverables
  • Statistical Analysis Systems (SAS) programming
  • Good Clinical Practice (GCP)
  • Biostatistics, clinical trials knowledge, data quality and data privacy standards

Johnson & Johnson Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.

  • Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
  • Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
  • Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.

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The Company
HQ: New Brunswick, NJ
143,612 Employees
Year Founded: 1886

What We Do

Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines

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