Clinical Data Science- Lead Biostatistician

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.
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