United States Pharmacopeia - Statistician

Roles and Responsibilities

1. Acts as an internal expert in statistical analyses and work closely with USP reference standard scientists.

2. Provides day to day support for study design, sampling strategies and data analysis to facilitate the development of candidates reference materials into USP Reference Standards,

3. Evaluates and analyzes testing data. Determines appropriate use of outlier tests

4. Prepares statistical analysis summary to accompany the reference standard candidate evaluation packages. Reviews and / or approves statistical reports prepared by other statistician.

5. Acts as point of contact related to statistical analysis for reference standards development.

6. Validates, updates and maintains spread sheets used by reference standard scientists

7. Participates in internal and external audits as needed.

8. Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities.

9. Keeps abreast of current trends and developments in related scientific fields, particularly in the area of statistical analysis for reference standards development.

10. Responds to stakeholder inquiries pertaining to reference standards statistical reports.

11. Represents USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.).

Desired Candidate Profile

Ph.D. degree in Statistics with a minimum of 3 years of relevant experience or

M.S. in statistics with minimum of 8 years of relevant experience