U.S. Pharmacopeial Convention Jobs

Job Information

The U.S. Pharmacopeial Convention (USP) Statistician in Hyderabad, India

Description

Summary of the Position

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 etc. In 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, critically review statistical reports prepared by other statistician, resolve issues using appropriate statistical means, works collaboratively with other functional areas within USP and as needed with expert committees.

Roles and Responsibilities

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

  • Provides day to day support for study design, sampling strategies and data analysis to facilitate the development of candidate’s reference materials into USP Reference Standards,

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

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

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

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

  • Participates 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 the area of 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.).

Basic Qualifications

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

Preferred Qualifications

  • Industry experience in support of a CMC or product development and quality environment is desirable. Experience in using statistical methods in support of certified reference materials and/or reference standards development is highly desirable

  • Experience with pharmaceutical and biotechnology product development.

  • Experience in development and evaluation of analytical methods for the characterization of biopharmaceutical products, specifically the statistical analysis aspects.

  • Experience with the development and analysis of study protocols for reference materials

  • Statistical design and analysis

  • Experience with the statistical aspects of validation

  • Understanding of pharmaceutical quality systems and associated regulatory framework is essential

  • Ability to write technical reports pertaining to the evaluation of materials testing and methods development.

  • Able to establish and nurture relationships with individuals of varying backgrounds and learning styles. Able to operate independently where appropriate, yet understands when to escalate issues and how to establish effective working relationships.

  • Excellent writing, interpersonal and communication skills (written and oral).

  • Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.

  • Knowledge of internet, electronic database searches, and statistical software industry.

  • Project Management skills. Must have 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.

  • Experience with, and knowledge of the USP-NF is preferred.

Supervisory Responsibilities

NA

Benefits

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

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements worldwide. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities. USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Note: As a condition of employment with United States Pharmacopeia- India Private Limited’s (USP), duty to provide and maintain a workplace that is free of known hazards, all employees and contingent staff hired after November 1st, 2021 are required to be fully vaccinated unless a a reasonable accommodation is approved.

Job Category Chemistry & Scientific Standards

Job Type Full-Time

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