Associate Director of Stats Programming

Associate Director of Stats Programming

Location: Irvine, California, United States
We are searching for the best talent 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

Lead a team of SAS and R programmers in the Medical Devices sector.
Program statistical deliverables for pre‑ and post‑market global clinical trials across all franchises.
Ensure programmed datasets, tables, reports and listings are accurate while meeting timelines and budgets.
Position Duties & Responsibilities

Provide leadership and direction for programming by establishing standards, 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.
Collaborate 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.
Collaborate 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 professionalism, ethics and compliance at all times.
Participate in compliance program‑related activities as directed by 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

Develop strategic partnerships with key internal stakeholders and external experts to lead implementation of industry programming standards.
Adapt ADaM and STDM standards for medical devices for use in the MD sector.
Build and develop talent through change to provide high quality programming capability.
Ensure high quality programming deliverables are delivered on time, within budget and in compliance to regulations and SOPs across all franchises.
Education & Experience Requirements

Bachelor’s degree in Statistics, Computer Science or related discipline.
At least 8 years of programming experience in clinical research within medical device or pharmaceuticals.
At least 3 years of supervisory experience.
Skills

Advanced Analytics
Biostatistics
Collaboration
Compliance Management
Courage
Critical Thinking
Data Privacy Standards
Data SynthesisData Visualization
` Developing Others
Good Clinical Practice (GCP)
Inclusive Leadership
Leadership
Program Management
Quality Assurance (QA)
Regulatory Affairs Management
Standard Operating Procedure (SOP)
Statistical Analysis Systems (SAS) Programming
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 residents, 56 hours for Washington residents)
Holiday pay, including floating holidays – 13 days per calendar year
Work, personal and family time – up to 40 hours per calendar year
Parental leave – 480 hours within one year of birth/adoption/foster care
Bereavement leave – 240 hours for an immediate family member (40 hours for an extended family member)
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
Additional benefits information available at https://www.careers.jnj.com/employee-benefits
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 applicants’ needs. If you are an individual with a disability and would like to request an accommodation, contact Johnson & Johnson via https://www.jnj.com/contact-us/careers or internal employees can contact AskGS to be directed to the accommodation resource.

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