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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.

About the job

The Associate Director of Clinical Data Science - Biostatistics will lead a team of statisticians within Johnson & Johnson MedTech's Electrophysiology business, supporting comprehensive evidence generation and the dissemination of scientific findings from clinical trials and post-market studies. This leader and their team will generate robust clinical evidence for the company’s devices, with a vital impact on patient lives. In collaboration with the Clinical Science & External Research (CSER) team, they will contribute to statistical design, analysis, and the development of scientific presentations and publications. This individual will be responsible for formulating and executing the statistical strategy in compliance with relevant regulations for post-market clinical trials across Johnson & Johnson MedTech Electrophysiology. They will ensure that all statistical analyses uphold the highest standards of scientific integrity while adhering to timelines and budgets.

This role is based in Irvine, CA and will work on a hybrid schedule.

Key Responsibilities:

• Provide leadership and strategic direction for the Biostatistics team supporting evidence generation from clinical trials and post-market studies in Johnson & Johnson MedTech’s Electrophysiology business, ensuring high-quality statistical support for scientific outcomes with a crucial impact on patient lives.
• Lead the development and execution of statistical strategies for collaborative clinical studies, including study design, data analysis, and reporting, to ensure the generation of high-quality evidence and successful outcomes.
• Collaborate closely with the Clinical Science & External Research (CSER) team to contribute to the design, analysis, and interpretation of data supporting scientific presentations, publications, and regulatory submissions.
• Oversee the planning and management of statistical activities, ensuring projects adhere to timelines, budgets, and regulatory guidelines for all evidence-generation initiatives.
• Stay current with advancements in biostatistics, innovative methodologies, and best practices, applying this knowledge to enhance study design and data analysis approaches.
• Ensure the highest levels of scientific integrity and quality in all statistical analyses, reports, and publications, maintaining compliance with applicable regulations and company standards.
• Manage, mentor, and develop the biostatistics team to foster technical excellence, continuous improvement, and professional growth.
• Collaborate with cross-functional teams, external partners, and vendors to ensure effective integration of statistical support and resource planning for evidence-generation projects.
• Drive process improvements within the biostatistics function, supporting corporate goals and ensuring the team's capability to meet the evolving needs of evidence dissemination.

Desired Skills and Experience:

• A PhD in Statistics or Biostatistics required.
• At least 6 years of experience in clinical research within Medical Device or Pharmaceuticals is required
• Demonstrated technical leadership in delivering critical milestones required.
• Excellent verbal and written communication skills required.
• Experience interacting with regulatory agencies required.
• Strong understanding of statistical inference and modeling, experimental design, data visualization, and reporting of statistical results is required.
• Experience programming with SAS or R required.
• Experience with both Frequentist and Bayesian methods is strongly preferred.
• Experience with observational data, causal inference, multiplicity adjustment, and Bayesian borrowing methods is strongly preferred.

The anticipated base pay range for this position is $174250 to $235750.

Bonus: - The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

The anticipated base pay range for this position is:

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