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J&J Family of Companies Manager, Statistical Programming in Irvine, California

Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year.

Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

The Manager of Programming will lead a team of programmers in the Medical Devices Sector. This individual will be accountable for the programming of statistical deliverables for pre- and post market global clinical trials across all Franchises. S/he ensures that programmed datasets, tables, reports and listings are accurate, while meeting timelines and budgets. The Manager of Programming will lead a team of programmers in the Medical Devices Sector. This individual will be accountable for the programming of statistical deliverables for pre- and post market global clinical trials across all Franchises. S/he ensures that programmed datasets, tables, reports and listings are accurate, while meeting timelines and budgets.

  • Provide leadership and direction for programmers by establishing programming standards, and mentoring and managing staff;

  • Implement and maintain a SAS platform that will allow efficient allocation of programming resources across all Franchises.

  • Develop and maintain a global SAS macro library in collaboration with Manager, Biostatistics;

  • Work with Data Management leadership to provide input on reporting processes and standards;

  • Provide oversight of all programming deliverables for clinical trials and support for any custom Data Management reports;

  • Develop and maintain global harmonized processes and procedures for programming;

  • Assist vendor evaluation, selection, contracting, and provide oversight activities for studies where programming is outsourced to a CRO;

  • Provide oversight of the quality review of all programming deliverables;

  • Work with BSDM partners, and leadership in Clinical Operations and Franchise to set priorities and develop plans for timely delivery of reports and metrics;

  • Ensure prompt resolution of critical report issues and provide timely and accurate responses to users;

  • Serve as the first line of contact for all report requests associated with clinical studies;

  • Train users in availability and understanding of delivered reports;

  • Ability to design, implement and maintain complex programming deliverables across a wide variety of clinical platforms and thereputic areas.

  • Strong proficiency in Base SAS, SAS/STAT and SAS Macro language. Advanced SAS certification preferred. Experience programming with R desirable;

  • Demonstrated ability to lead teams to deliver critical milestones;

  • Experience with CDISC datasets, tables , listings and figures preferred;

  • Familiarity with regulatory requirements for report submissions;

  • Excellent verbal and written communication skill

  • 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.

Qualifications

  • A Master’s degree or equivalent in Statistics , Computer Science or related discipline.

  • A minimum of 8 years of system support in clinical research within Medical Device or Pharmaceuticals.

  • A minimum 1 year of supervisory experience.

Primary Location

United States-California-Irvine-29A Technology Dr

Organization

Biosense Webster Inc. (6010)

Job Function

R&D

Requisition ID

2105933265W

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