• Bachelor Science Statistics or equivalent in Education and Experience
• 5 years applicable experience
• Prior knowledge and applications of statistical methods in the pharmaceutical industry is preferred for this job since it requires analyses and interpretation of complex pharmaceutical data sets on a large scale.
• Bachelor Science Statistics
• Knowledge of cGMP’s/FDA and other Regulatory requirements
• Experience in areas of statistical programming, hypothesis testing, data management and scientific report writing
• Excellent statistical computation skills, including expertise with SAS
• Demonstrated skill in unstructured problem solving and critical thinking
• Strong written and verbal communication skills
The Statistician will execute assigned activities for technical statistics support related to new products, processes, equipment, and revisions/modifications to current products, processes, equipment.
• Interact with other statisticians and other departments in a team environment to support various statistical activities related to process improvement projects, process validation plans, technology transfer projects, product and process quality issues.
• Perform trend analysis and hypothesis testing on QA laboratory and in-process data.
• Perform product expiry analysis.
• Assist in experimental design process by analyzing data collected in response to product investigations and validations.
• Provide statistical displays and analyses for technical reports and Periodic Product Reviews (PPR).
• Develop and execute quality assurance plans to test both database extractions and complex analyses of stability, product release, and manufacturing data.
• Ability to work with large databases using SAS, SQL, Microsoft Access, and other related data mining tools.
• Participate in EITs, as required, to provide technical input.
• Participate in teams to present statistics analysis during Internal and External Regulatory inspections and prepare responses to deficiency reports.
• Perform other duties as assigned.
You may apply for this position online by selecting the Apply now button.
GlaxoSmithKline is an equal opportunity employer, M/F/D/V - and we are proudly committed to diversity in our workforce.
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GlaxoSmithKline - 14 months ago
GlaxoSmithKline plc (GSK) is a global healthcare group, which is engaged in the creation and discovery, development, manufacture and...