Location: Irvine, California, United States of America
Job Description
Johnson & Johnson is searching for an Associate Director of Stats Programming to support our Electrophysiology business. This role will work onsite in our Irvine, CA office following a hybrid schedule.
Overall Responsibilities
The Programming Leader will lead a team of SAS and R 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, ensuring datasets, tables, reports and listings are accurate while meeting timelines and budgets.
Position Duties & Responsibilities
- Provide leadership and direction for programming by establishing standards, and mentoring and managing staff
- Implement and maintain SAS and R platforms to allow efficient allocation of programming resources
- Develop and maintain global SAS macro and R function libraries
- Work with Data Management leadership to provide input on data and process standards
- Provide oversight of all programming deliverables for clinical trials
- Develop and maintain global harmonized processes and procedures for programming
- Lead vendor evaluation, selection, contracting and oversight activities for studies where programming is outsourced to a CRO
- Work with Clinical Data Science partners and leadership in Clinical Operations and Franchise to set priorities and develop project management plans for trial execution, including timelines, milestones and budgets
- Provide oversight of the quality review of all programming deliverables
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
- Diligently participate in compliance program‑related activities as directed by the supervisor or Chief Compliance Officer
- Perform other related duties as required
Functional and Technical Competencies
- Demonstrated ability to lead teams to deliver critical milestones
- Strong proficiency in Base SAS, SAS/STAT and SAS Macro language; Advanced SAS certification preferred
- Strong proficiency in R; advanced R programming preferred
- Experience with CDISC datasets, tables, listings and figures preferred
- Excellent verbal and written communication skills
Leadership Competencies
- Connect – Develop strategic partnerships with key internal stakeholders and external experts to lead implementation of industry programming standards
- Shape – Develop knowledge of therapeutic areas within the franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector
- Lead – Build and develop talent through change to provide high‑quality programming capability
- Deliver – Ensure high‑quality programming deliverables for clinical programs are delivered on time, within budget and in compliance with regulations and SOPs, seamlessly across all franchises
Education & Experience
- Bachelor’s degree in Statistics, Computer Science or related discipline, with at least 8 years of programming experience in clinical research within Medical Device or Pharmaceuticals, and at least 3 years of supervisory experience
Compensation
Base pay range: $137,000.00 - $235,750.00
Benefits
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year (48 hours for Colorado, 56 hours for Washington)
- Holiday pay – 13 days per calendar year (including Floating Holidays)
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member, 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52‑week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time‑Off – 80 hours per calendar year
Equal Opportunity Employer
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, external applicants please contact us via Internal employees should contact AskGS to be directed to your accommodation resource.
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