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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 into PQV workflows and investigations.

• **Documentation & Training:**

Support updates to trending procedures, contribute to statistical whitepapers, and assist in developing training materials to build statistical literacy across PQV teams.

• **Pilot & Deployment Support:**

Participate in desktop exercises and pilot studies, and support scale-up of validated tools and methodologies.

Qualifications

+ Master’s degree in Biostatistics, Statistics, Mathematics, or related field.

+ 4–6 years of experience in statistical analysis, preferably in pharmaceutical or regulated industries.

+ Proficiency in statistical software (e.g., R, SAS, Python) and data visualization tools (e.g., Tableau, Power BI).

+ Familiarity with statistical process control methods, including Nelson Rules.

+ Experience with complaint trending, signal detection, or pharmacovigilance is a plus.

+ Strong analytical, communication, and collaboration skills.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Biostatistics, Clinical Pharmacology, Communication, Data Science, Regulatory Requirements

Preferred Skills:

Audit Management, Business Savvy, Coaching, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)