Onsite Product Quality Vigilance Analyst – Statistician

Posted 5 hours ago

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About the role

  • Biostatistician supporting signal detection and trending analysis in a pharmaceutical setting. Collaborating cross-functionally within the Product Quality Vigilance team to enhance data methodologies and insights.

Responsibilities

  • 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.

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

Benefits

  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • up to 120 hours of vacation per calendar year
  • up to 40 hours of sick time per calendar year
  • holiday pay, including Floating Holidays – up to 13 days per calendar year
  • up to 40 hours of personal and family time per calendar year

Job title

Product Quality Vigilance Analyst – Statistician

Job type

Experience level

Mid levelSenior

Salary

$112,200 - $151,800 per year

Degree requirement

Postgraduate Degree

Tech skills

Location requirements

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