Johnson & Johnson MedTech · 2 days ago
Product Quality Vigilance (PQV) Analyst - Statistician
Horsham, PA
Full-time
Onsite
Mid, Senior Level
4+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to preventing and treating complex diseases. The Product Quality Vigilance (PQV) Analyst - Statistician will provide statistical guidance and develop tools to enhance product quality complaint trending processes within a global pharmaceutical environment.
Hospital & Health Care
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
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
Strong analytical, communication, and collaboration skills
Preferred
Experience with complaint trending, signal detection, or pharmacovigilance is a plus
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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