Product Quality Vigilance (PQV) Analyst - Statistician

Johnson & Johnson Innovative Medicine • Horsham, PA

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About The Position

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.

Requirements

• Master’s degree in Biostatistics, Statistics, Mathematics, or related field - preferred.
• 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.

Nice To Haves

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

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level