Job Function:
Data Analytics & Computational Sciences
Job Sub Function:
Biostatistics
Job Category:
People Leader
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 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 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. S/he ensures that programmed datasets, tables, reports and listings are accurate, while meeting timelines and budgets.
POSITION DUTIES & RESPONSIBILITIES:
Reporting to the Sr. Director, Biostatistics and Data Management, this individual will;
- 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.
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 to regulations and SOPs, seamlessly across all Franchises
EDUCATION & EXPERIENCE 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.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Collaboration, Compliance Management, Courage, Critical Thinking, Data Privacy Standards, Data Synthesis, Data 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
The anticipated base pay range for this position is :
$137,000.00 - $235,750.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
