Serve as a subject matter expert in biostatistics, providing guidance to PQV stakeholders on appropriate statistical methods for signal detection, trending, and data interpretation.
Design, validate, and refine statistical tools and models 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.

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
Experience with complaint trending, signal detection, or pharmacovigilance is a plus
Strong analytical, communication, and collaboration skills.

Product Quality Vigilance Analyst – Statistician

Key skills