About

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 https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America Job Description: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are currently recruiting for a Lead Statistical Programmer to join our team based in Irvine, CA. This role can be based in any of the J&J MedTech locations. This person will be responsible for development and generation of analysis datasets, tables, listings, and graphs from assigned clinical sources using SAS and/or R; mentoring, training and support of junior team members; leading development and maintenance of associated operating procedures; and representing the organization in external industry forums (e.g., CDISC, SDTM, and User Groups). Mentors junior staff on all aspects of programming. This individual performs with little to no supervision on complex deliverables. RESPONSIBILITIES: Utilize programming standards to develop efficient and accurate programs using SAS Support and maintain a SAS platform for efficient programming practices Support creating and/or maintaining Programming Infrastructure in SAS Develop and maintain a global SAS macro library Familarity with basic R for developing and maintaining R programs for data analysis, statistical modeling, and visualization is required Work with Data Management leadership to provide input on reporting processes and standards Oversee programming deliverables for studies Develop and maintain global harmonized processes and procedures for programming Assist with vendor evaluation, selection, contracting, and provide oversight activities (as needed) for studies where programming is outsourced to a CRO Provide oversight of the quality review of all programming deliverables Work with Clinical Data Science (CDS) partners, and leadership in Clinical Operations and Franchise to develop plans for timely delivery of reports, metrics and study deliverables Ensure prompt resolution of critical report issues and provide timely and accurate responses to users (as required) Serve as alternate line of contact for all report requests associated with clinical studies Assist in training users in availability and understanding of delivered reports Mentor junior team member to ensure efficient and consistent programming practices Ability to design, implement and maintain complex programming deliverables across a wide variety of clinical platforms and thereputic areas Functional and Technical Competencies: Proficiency in Base SAS, SAS/STAT and SAS Macro language. Advanced SAS certification desirable Familiarity with basic R programming is required Demonstrated ability to lead teams to deliver critical milestones Familiarity with regulatory requirements for report submissions Strong debugging, problem-solving and documentation skills Excellent communication and cross-functional collaboration skills Expertise in/exposure to R syntax, functions, and packages is preferred Ability to manage multiple priorities under tight timelines Leadership Competencies: Connect – Foster strategic partnerships with Clinical System and Biostatistics at the Enterprise level to ensure MD programming practices meet the needs of the organization Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and SDTM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine SDTM standards Lead – build and develop talent through mentorship and consultation to provide high quality programming capability Deliver – ensure high quality programming deliverables for clinical programs are delivered on time and in compliance to regulations and SOPs, seamlessly across all Franchises EDUCATION & EXPERIENCE REQUIREMENTS: A Bachelor’s degree in Statistics, Computer Science or related discipline (required) Minimum 6 years of system support in clinical research within Medical Device or Pharmaceuticals Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. The anticipated base pay range for this position is $124,950 to $169,050. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. The anticipated base pay range for this position is : Additional Description for Pay Transparency: 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 https://www.jnj.com/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information