Statistician, Reference Standards Evaluation

Key Responsibilities:

• Act as an internal expert in statistical analyses and collaborate with reference standard scientists
• Provide support for study design, sampling strategies, and data analysis
• Evaluate and analyze testing data, including determining appropriate outlier tests
• Prepare statistical analysis summary reports for reference standard candidate evaluation packages
• Review and approve statistical reports prepared by another statistician
• Act as a point of contact for statistical analysis related to reference standards development
• Participate in internal and external audits as necessary
• Keep updated on current trends in statistical analysis for reference standards development
• Represent USP at professional meetings and maintain relationships with stakeholders

Qualifications Required:

• MS in statistics with a minimum of 3+ years of relevant experience
• Industry experience in a CMC or product development and quality environment
• Experience using statistical methods and tools for reference standards development
• Knowledge of statistical design and analysis for study protocols and method validation
• Ability to write technical reports on materials testing and method development
• Proficiency in statistical software such as SAS, JMP, Minitab, and R
• Understanding of pharmaceutical quality systems and regulatory frameworks
• Project management skills with the ability to prioritize multiple projects
• Excellent communication skills to interact with diverse stakeholders