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Stability Statistician-Analytical Chemistry Job
Date: Oct 28, 2009
Location: Rochester, NY, 14673, USA
Job Title:
Stability Statistician-Analytical Chemistry
Req #:
5350BR
Job Description:
Provides statistical analysis for chemical data. Supports the global pharmaceutical, vision care, and surgical stability programs; providing analysis and trending of stability data for regulatory filings and technical assessments of stability specifications. Run regression analysis and use various statistical methodologies to provide insight to shelf-life/expiry dates, temperature statbility, etc.
Job Duties:
- Acquire and develop appropriate statistical software tools to interface with a laboratory LIMS system, provide suitable statistical trending of data, and generate reports and tables in formats suited for regulatory submission - Interact with product development teams to support stability analysis for new product development and regulatory submissions. -Respond to regulatory agency questions. - Interact with internal and external contacts at a variety of levels, including Regulatory Affairs, Analytical Research & Development, Formulations Development, and Process Development. - Establish expiry dating for Clinical Trial Material across all business units.
Qualifications
-
Education:
M.S. or Ph.D. in (Applied Statistics preferred). -4-6 years of Industry experience; experience with stability programs desirable but not required. -Applicants must have experience in the statistical analysis of research data. -Previous experience performing linear and non-linear regression analysis and/or pharmacokinetics analysis desired. -Knowledge of stability requirements within the pharmaceutical industry desirable but not required. -
Special Skills:
Strong statistical analysis, use of statistical software packages, and technical writing skills. Demonstrated success in working in a multidisciplinary team/ collaborative environment. -use and knowledge of FDA/ICH Q1E stability analysis package a plus. -Proven organizational and project planning skills. Strong problem solving skills, the ability to multi-task, strong verbal and written communication skills with customer service orientation and the ability to work effectively with various functional areas within the company. -Specialized Training: Experience with compiling stability reports for regulatory submissions a plus.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes
Status Full-Time
Stability Statistician-Analytical Chemistry
Req #:
5350BR
Job Description:
Provides statistical analysis for chemical data. Supports the global pharmaceutical, vision care, and surgical stability programs; providing analysis and trending of stability data for regulatory filings and technical assessments of stability specifications. Run regression analysis and use various statistical methodologies to provide insight to shelf-life/expiry dates, temperature statbility, etc.
Job Duties:
- Acquire and develop appropriate statistical software tools to interface with a laboratory LIMS system, provide suitable statistical trending of data, and generate reports and tables in formats suited for regulatory submission - Interact with product development teams to support stability analysis for new product development and regulatory submissions. -Respond to regulatory agency questions. - Interact with internal and external contacts at a variety of levels, including Regulatory Affairs, Analytical Research & Development, Formulations Development, and Process Development. - Establish expiry dating for Clinical Trial Material across all business units.
Qualifications
-
Education:
M.S. or Ph.D. in (Applied Statistics preferred). -4-6 years of Industry experience; experience with stability programs desirable but not required. -Applicants must have experience in the statistical analysis of research data. -Previous experience performing linear and non-linear regression analysis and/or pharmacokinetics analysis desired. -Knowledge of stability requirements within the pharmaceutical industry desirable but not required. -
Special Skills:
Strong statistical analysis, use of statistical software packages, and technical writing skills. Demonstrated success in working in a multidisciplinary team/ collaborative environment. -use and knowledge of FDA/ICH Q1E stability analysis package a plus. -Proven organizational and project planning skills. Strong problem solving skills, the ability to multi-task, strong verbal and written communication skills with customer service orientation and the ability to work effectively with various functional areas within the company. -Specialized Training: Experience with compiling stability reports for regulatory submissions a plus.
Work Location NY - Rochester-1400 N Goodman Street Relocation Available Yes
Status Full-Time
Nearest Major Market: Rochester
Job Segments: Chemical, Engineering
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