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Johnson & Johnson · 1 month ago

Product Quality Vigilance (PQV) Analyst - Statistician

Horsham, Pennsylvania, United States of America

Full-time

Hybrid

Mid, Senior Level

4+ years exp

Johnson & Johnson is a leader in healthcare innovation, dedicated to developing treatments and solutions that profoundly impact health for humanity. They are seeking a Product Quality Vigilance (PQV) Analyst - Statistician to support the development and implementation of statistical tools and methodologies that enhance product quality complaint trending processes. This role involves statistical guidance, tool development, data analysis, and cross-functional collaboration within the PQV team.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

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

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

Analyze complaint data from systems and BI tools. Support visualizations and dashboards to support real-time signal detection and communication

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

Partner with Process Insights, Product Insights, Trending Analysts, and the Trending Manager to ensure statistical methodologies are integrated into PQV workflows and investigations

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

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

Qualification

BiostatisticsStatistical AnalysisStatistical SoftwareData VisualizationSignal DetectionCommunicationCollaboration

Required

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

Biostatistics

Clinical Pharmacology

Communication

Data Science

Regulatory Requirements

Preferred

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)

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)