Statistician, Reference Standards Evaluation

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a hands-on non-supervisory role that supports the statistical design of experiments and evaluation of data in support of reference standards development certified reference materials method validation uncertainty calculations this role the incumbent will provide statistical expertise and works closely with reference standards scientists in the area of design of experiments statistical analyses using a variety of statistical approaches and tools. Critically review statistical reports prepared by another statistician and resolve issues using appropriate statistical means. Work collaboratively with other functional areas within USP and as needed with expert committees.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Statistician has the following responsibilities:

• Acts as an internal expert in statistical analyses and works closely with USP reference standard scientists.
• Provides day-to-day support for study design sampling strategies and data analysis to facilitate the development of candidates materials into USP Reference Standards.
• Evaluates and analyzes testing data. Determines appropriate use of outlier tests.
• Prepares statistical analysis summary report to accompany the reference standard candidate evaluation packages.
• Reviews and/or approves statistical reports prepared by another statistician.
• Acts as point of contact related to statistical analysis for reference standards development.
• Validates updates and maintains spread sheets used by reference standard development.
• Participate in internal and external audits as needed.
• Communicates and maintains working relationships with other USP departments regarding projects related to validation studies methods development reference standards and other cross-cutting activities.
• Keeps abreast of current trends and developments in related scientific fields particularly in statistical analysis for reference standards development.
• Responds to stakeholder inquiries pertaining to reference standards statistical reports.
• Represents USP at professional meetings (scientific meetings organized by USP and other organizations meetings at other pharmacopeias or regulatory agencies etc.).

Who is USP Looking For

The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:

• statistics with a minimum of 3 years of relevant experience.
• Industry experience in support of a CMC or product development and quality environment is required.
• Experience in using statistical methods and tools in support of reference standards and/or certified reference materials development is highly desirable.
• Experience with statistical design and analysis of study protocols for reference materials.
• Experience with the statistical aspects of method validation.
• Ability to write technical reports about the evaluation of materials testing methods development and validation.
• Excellent writing interpersonal and communication skills (written and oral).
• Working experience with various statistical software like SAS JMP Minitab and R.
• Understanding of pharmaceutical quality systems and the associated regulatory framework
• Project Management skills. Must have the ability to prioritize and manage multiple concurrent projects with often long-life cycles.
• Must be able to share technical information with non-technical or non-scientific staff and to communicate effectively with representatives from pharmaceutical companies government and academic institutions. Ability to persuade corporations to collaborate with USP on various projects.

Additional Desired Preferences

• Experience with pharmaceutical and biotechnology product development.
• Experience in the development and evaluation of analytical methods for the characterization of pharmaceutical products specifically the statistical analysis aspects.
• Able to establish and nurture relationships with individuals of varying backgrounds and learning styles. Able to operate independently where appropriate and understands when to escalate issues and how to establish effective working relationships.
• Well-developed organizational interpersonal communications negotiation writing and strong listening skills.
• Experience with and knowledge of the USP-NF is preferred.

Supervisory Responsibilities

None this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial well-being is protected.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under a specificwritten agreement with USP.