At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are recruiting for a Senior Clinical Programmer (SDTM Programming) Locations US and Canada.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease and the development of best-in-industry data science capabilities is critical to our ambition to be most innovative healthcare company.

Within Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) we are looking for individuals with the motivation to contribute to the growth of our Clinical Programming team. The Clinical Programming team within C&SP is responsible for SDTM submission-ready deliverables (SDTM specifications, aCRF, datasets, xpt, define.xml, cSDRG), back-end edit checks, listings, tables, to support data cleaning and review activities.

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.

This position is a member of the clinical programming team and is capable of supporting programming activities with minimal guidance and may contribute to departmental innovation and process improvements. 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.

Responsibilities Include:

• Create and/or review internal Data Review Model (DRM) and SDTM mapping specifications, aCRF, datasets, define.xml, cSDRG for stakeholder use (data cleaning, medical review, central monitoring, adaptive decision making, etc.)

• Create back-end edit checks, data cleaning and review listings, tables

• Independently manages interfaces and escalations with cross-functional project teams.

• Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of next-generation data strategy (R, Python, Scala, Java, etc.).

QUALIFICATIONS

EDUCATION:

• Bachelor’s degree in Computer, Data or Life Sciences or equivalent work experience is required; Master’s degree preferred

EXPERIENCE AND SKILLS:

Bachelor’s degree in Computer, Data or Life Sciences or equivalent work experience is required; Master’s degree preferred

• 4+ years of relevant experience in pharmaceutical industry is desired, experience in other industries in programming role will also be considered

• In-depth knowledge of protocol, current clinical drug development processes preferred

• 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.

• Demonstrated written and verbal communication skills

• Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred

• Vendor management oversight experience required

OTHER:

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.

PRIMARY LOCATION

United States-Pennsylvania-Wayne-955/965 Chesterbrook Blvd

OTHER LOCATIONS

North America

ORGANIZATION

Janssen Research & Development, LLC (6084)

JOB FUNCTION

R&D

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