Associate Director of Stats Programming

Johnson & Johnson Innovative Medicine • Irvine, CA

6d • Hybrid

About The Position

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. This role will support our Electrophysiology business and will work onsite in our Irvine, CA office, following a hybrid schedule. 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. S/he ensures that programmed datasets, tables, reports and listings are accurate, while meeting timelines and budgets.

Requirements

• A 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.
• Strong proficiency in Base SAS, SAS/STAT and SAS Macro language.
• Strong proficiency in R, advanced R programming preferred.
• Experience with CDISC datasets, tables, listings and figures preferred.
• Excellent verbal and written communication skills.
• Demonstrated ability to lead teams to deliver critical milestones.
• 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 to regulations and SOPs, seamlessly across all Franchises.

Nice To Haves

• Advanced SAS certification preferred.
• Advanced R programming preferred.
• Experience with CDISC datasets, tables, listings and figures preferred.

Responsibilities

• Provide leadership and direction for Programming by establishing programming standards, and mentoring and managing staff.
• Implement and maintain SAS and R platforms that will 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 denoted by the supervisor or Chief Compliance Officer.
• Performs other related duties as required.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• 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 the 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
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager