Description
Large Pharmaceutical Compnay is seeking a qualified Statistician to joing their Statistics departemten on a consultant basis for 12 months. This position could easily turn into a long term contrat or Permanent role.Preferred qualifications:
* MS 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
Key Responsibilities:
* 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.
To find out more about Real Staffing please visit www.realstaffing.com