Product Quality Vigilance (PQV) Analyst - Statistician

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:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Horsham, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for Product Quality Vigilance (PQV) Analyst - Statistician to join our Product Quality Vigilance (PQV) team located in Horsham, Pennsylvania

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Join our Product Quality Vigilance (PQV) team as a Biostatistician and help shape the future of signal detection and trending in a dynamic, global pharmaceutical environment.

This analyst-level role is a key contributor to our PQV Operating Model, supporting the development and implementation of statistical tools and methodologies that enhance the sensitivity, robustness, and responsiveness of our product quality complaint trending processes.

Key Responsibilities

·       Statistical Guidance & Consultation:
Serve as a subject matter expert in biostatistics, providing guidance to PQV stakeholders (e.g., Trending Analysts, PQM, Process/Product Insights leads) on appropriate statistical methods for signal detection, trending, and data interpretation.

·       Statistical Tool Development:
Design, validate, and refine statistical tools and models (e.g., Nelson Rules, Pareto analysis, QTL, risk scoring, dynamic trending) to enhance the sensitivity and robustness of product quality complaint trending.

·       Data Analysis & Visualization:
Analyze complaint data from systems and BI tools.

Support visualizations and dashboards to support real-time signal detection and communication.

·       Methodology Support:
Compare parametric vs.

non-parametric approaches, assess sensitivity and scalability, and contribute to decision matrices for trending method selection across product types and lifecycle stages.

·       Cross-Functional Collaboration:
Partner with Process Insights, Product Insights, Trending Analysts, and the Trending Manager to ensure statistical methodologies are integrated...