Summary of the Position: This is a hands-on non-supervisory scientific position in the General Chapters Group within the Science division. The incumbent is responsible for providing support in the development and revision of general USP-NF chapters mostly related to Statistics and metrology and supports USP Expert Committees and associated Expert Panels. The position also require evaluation of data in support of reference standards development, critically review statistical reports prepared by other statistician, resolve issues using appropriate statistical means, works collaboratively with other areas within USP and provide statistical support to all USP volunteers body These activities will require the critical evaluation of relevant documents and other information, the performance of literature searches on related topics and the development and drafting of pertinent documents for other scientific staff and/or Expert Committee review. Roles and Responsibilities : 1. Oversees and facilitates all aspects of the development of General Chapters to the USP-NF, from development of the initial proposal to the publication of the documentary standard. Evaluates and analyzes supporting data, and translates into USP editorial style and format. 2. Acts as an internal expert in statistical analyses and work closely with USP scientists and expert committees, and 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. 3. Assists in the activities of the USP Expert Committees and Advisory Panels, as needed. 4. Responds to telephone and written inquiries pertaining to USP-NF monographs and General Chapters included in the USP-NF. 5. Communicates and maintains working relationships with other USP departments regarding projects related to validation studies, methods development, reference standards, and other cross-cutting activities. 6. Keeps abreast of current trends and developments in related scientific fields. 7. Serves as representative of USP at professional meetings (scientific meetings organized by USP and other organizations, meetings at other pharmacopeias or regulatory agencies etc.). Gives public presentations on USP matters (as assigned). 8. Performs other related duties as required. Basic Qualifications : Ph.D. in Statistics a minimum of 8 years, or M.S. and 10 years of relevant experience with USP-NF test and standards required. Minimum of 8 years of experience with statistical analysis of QA/QC data including validation of analytical procedures, acquired working in the pharmaceutical industry. Knowledge on metrological aspects of measurements (e.g. uncertainty). Knowledge of regulatory requirements and guidelines for pharmaceuticals (e.g. FDA, ICH, etc) Preferred Qualifications : - Knowledge in QbD tools. - Experience in development and evaluation of analytical methods including bioassays, specifically the statistical analysis aspects. - Industry experience in support of a CMC or product development and quality environment is desirable. - 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. - Strong presentation and communication skills (written and oral). - Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills. Knowledge of internet and electronic database searches helpful. - Practical experience in scientific, analytical techniques. - Project Management skills required. Knowledge of the pharmaceutical industry and the associated regulatory framework is essential. - Ability to prioritize tasks and manage multiple projects simultaneously. 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. - Knowledge on Chemometrics is a plus Supervisory Responsibilities : None 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.

Hyderabad

United States Pharmacopeia - Principal Scientist/Statistician 

United States Pharmacopeia - Principal Scientist/Statistician  ,Job Description for United States Pharmacopeia - Principal Scientist/Statistician  in United States Pharmacopeia-India (P) Limited in  Hyderabad for (8-12) years of experience. Apply Now!

Job Description for United States Pharmacopeia - Principal Scientist/Statistician  in United States Pharmacopeia-India (P) Limited in  Hyderabad for (8-12) years of experience. Apply Now!