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Job Information

J&J Family of Companies Senior Clinical Programmer in Titusville, New Jersey

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Clinical Programmer. This position can be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Remote locations within North America may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Senior Clinical Programmer Lead will be 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 Senior Clinical Programmer will be responsible for oversight or the development of one or more clinical data management trial activities of moderate to high complexity/criticality. This will include data model specifications, data stream integrations and transformation of source to internal data models and/or CDISC submission ready Study Data Tabulation Model (SDTM) tabulation packages (aCRF, define.xml, cSDRG, etc.). Create and execute edit check programs, listings and report solutions to aid in monitoring of safety, risk, compliance and ensures quality data review.

This position will be a member of the Clinical Programming team and will be capable of supporting programming activities with minimal guidance and may contribute to departmental innovation and process improvements. This individual 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.

Principal Responsibilities:

  • Accountable for one or more clinical programming trial activities of moderate to high complexity, scope and/or criticality.

  • Perform comprehensive review of, and provide input into, project requirements and documentation. Identify gaps, propose solutions and apply expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Provide technical and project specific guidance to team members to ensure high quality and on-time deliverables in compliance with departmental processes.

  • Ensure 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 submission ready CDISC SDTM. Design mapping algorithms for non‐standard conversions.

  • Creation or review of internal data model 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, cross and 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.

  • Oversee activities outsourced to vendors adopting appropriate processes and methods to ensure their performance meets the agreed upon scope, timelines, and quality, as applicable.

  • Collaborate effectively with team and cross-functional counterparts and vendors to achieve project goals.

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

  • Support and/or lead in developing and implementing process, system and tool improvement initiatives within compliance with departmental processes and procedures.

  • Ensure continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position.

  • The position may mentor and coach others.

Qualifications

  • A minimum of a Bachelor’s degree is required, preferably in Computer, Data Science/Data Engineering, Mathematics or a related scientific discipline. Advanced degree (Master’s, PhD) preferred.

  • A minimum of 4 years of clinical programming/clinical data management experience is required.

  • Experience in a pharmaceutical/clinical trial environment is preferred.

  • Knowledge of protocol and current clinical drug development processes preferred.

  • Knowledge of regulatory guidelines, such as Good Clinical Practices (GCP)/International Council for Harmonization (ICH) and relevant clinical R&D concepts is preferred.

  • Knowledge of data structures and relevant programming languages for data manipulation and reporting (i.e. SQL, R, Python, etc.) is preferred.

  • Knowledge of SAS is required.

  • Knowledge of CDISC SDTM is required.

  • Project management skills required.

  • Experience with vendor management and oversight is preferred.

  • Experience working on cross-functional teams is preferred.

  • Must have excellent written and verbal communication skills.

  • Must have strong analytic, problem-solving and organizational skills.

  • The ability to communicate technical information in a non-technical fashion is required.

  • The ability to collaborate with all levels of management across a global matrix organization is required.

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.

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Other Locations

North America-United States-New Jersey-Raritan, North America-United States-New Jersey-Titusville

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2105928429W

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