Associate Director, Statistical Programming

Job description

Johnson & Johnson's Family of Companies is recruiting for an Associate Director, Statistical Programming to be located in Irvine, Ca.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Programming Leader will lead a team of SAS 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.

Reporting to the Sr. Director, Biostatistics and Data Management, the Associate Director will:

• Provide leadership and direction for Programming by establishing programming standards, and mentoring and managing staff;
• Implement and maintain a SAS platform that will allow efficient allocation of programming resources across all Franchises;
• Develop and maintain a global SAS macro library;
• 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 BSDM partners, and leadership in Clinical Operations and Clinical Science 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.

Desired profile

Qualifications :

• 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 is required.
• Experience leading implementation of industry programming standards including SDTM and ADam is required.
• Experience building and development of talent(teams) through change to provide high quality programming capability is required.
• Regulatory submission experience in a fast paced environment is required .
• Strong proficiency in Base SAS, SAS/STAT and SAS Macro language is required.
• Advanced SAS certification and/or experience programming with R is preferred.
• Experience with CDISC datasets, tables, listings and figures is preferred.
• Excellent verbal and written communication skills is required.
• Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery is preferred.
• Demonstrated ability to lead teams to deliver critical milestones is required.