At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Data Analytics & Computational Sciences **Job Sub** **Function:** Biostatistics **Job Category:** Scientific/Technology **All Job Posting Locations:** Irvine, California, United States of America **Job Description:** 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 Role:** The **Clinical Data Science - Lead Biostatistician** will serve as a technical expert within Johnson & Johnson MedTech’s Electrophysiology business, supporting critical evidence-generation activities through robust statistical analyses and innovative methodological applications. Reporting to the Clinical Data Science – Associate Director of Biostatistics, this individual will contribute to study design, analysis, and scientific dissemination, ensuring the delivery of high-quality, compliant, and impactful clinical data. This role offers an excellent opportunity to influence patient outcomes while working in a collaborative, fast-paced environment. This is a hybrid role based in Irvine, CA **Key Responsibilities:** + Provide expert statistical input for clinical trial design, analysis plans, and reporting, ensuring scientific rigor, regulatory compliance, and strategic alignment in support of device evidence generation. + Independently develop statistical analysis plans for diverse phases of clinical studies. Review protocols and case report forms (CRFs) to ensure proper design and methodology. + Perform data analysis, prepare statistical reports, and contribute to scientific publications and presentations, working closely with cross-functional teams and external partners. + Support the preparation of documentation for regulatory submissions, including statistical sections, ensuring adherence to regulatory standards and guidelines. + Stay current with advances in statistical methods, integrating them into study strategies as appropriate. + Maintain high standards of scientific integrity across all analyses, reports, and publications, ensuring compliance with company policies, SOPs, and regulatory requirements. + Write comprehensive study documentation, statistical analysis plans, and reports. Present complex data analysis results clearly to technical and non-technical stakeholders. + Collaborate effectively with cross-functional teams, external vendors, and regulatory bodies to ensure scientific and regulatory excellence. **Desired Skills & Experience:** + PhD or Master’s degree in Statistics, Biostatistics, or related quantitative field. + Minimum of 6 years of relevant experience in clinical research within Medical Device or Pharmaceuticals, with demonstrated expertise in statistical design, analysis, and reporting. + Deep knowledge of statistical inference, modeling, experimental design, Bayesian and frequentist methodologies. + Experience with observational studies, causal inference, multiplicity adjustments, and Bayesian borrowing approaches preferred. + Proficient in SAS, R, or equivalent statistical programming tools. + Strong communication skills, with the ability to clearly convey complex statistical concepts. + Familiarity with regulatory processes and experience interacting with agencies such as the FDA is advantageous. **The anticipated base pay range for this position is $124,950 to $169,050.** **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)).** **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 :** Additional Description for Pay Transparency: