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About the role
- Biostatistician developing statistical tools for complaint trending in pharmaceutical industry. Collaborating with cross-functional teams to enhance product quality methodologies.
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.
- 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
- pension plan (retirement) and savings plan (401(k))
- vacation – up to 120 hours per calendar year
- sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- holiday pay, including Floating Holidays – up to 13 days per calendar year of Work
- Personal and Family Time - up to 40 hours per calendar year
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