Statistician

Jobs Title: Statistician

Location: Tempe, Arizona


Jobs Description:

High proficiency with statistical software (SAS, R, Minitab, jmp) SAS base certification a plus. 
Strong data manipulation skills including: SQL generation and the ability to combine query results from multiple sources for analysis (using SAS, R, Business Objects and working with Oracle and SQL Server databases 
5 years’ experience in device or drug industry complaint handling, analysis or other safety clinical data, or customer service/technical evaluation analysis. 
Strong communication skills, oral and written. 
Experience with one or more programming languages/platforms: -net development environment -java development tools -Matlab -Visual Basic for Applications 
Spreadsheet modeling skills 
Strong analytical skills including proficiency with parametric and non-parametric actuarial survival, bootstrap / Monte Carlo methods, ANOVA / Designed Experiments, SPC / Change point Analysis.
Applies statistical knowledge to the design of clinical studies. 
This requires calculation of sample size and power, as well as solicitation of appropriate design assumptions from other staff and from published literature.
Participate in development and documentation of study protocols with responsibility for scientific soundness sections, which include statistical hypotheses, sample size calculations, and analysis methods for meeting the study objectives, in collaboration. 
Provide statistical analysis and trending of data originating from product comment reports, returned product analysis, 
spontaneous reports, registries, post approval studies, and of Neuro products and therapies. 
Assist in monitoring of product performance trends from a risk management perspective, and collaborate with business partners to develop solutions to reduce current and future risk and improve long-term safety. 
Develop process and define requirements for systems and tools (e.g. complaint handling codes) to perform simple and complex analysis of product and clinical performance data for current and future products and therapies. 
Maintain competency in data analysis techniques and tools, and keep the business informed of emerging standards and best practices for monitoring of product safety data. 
Integrate data source(s), using appropriate statistical methodology and data collection strategies, in order to provide ongoing monitoring relative to developed acceptance criteria. 
Apply technical knowledge to critically interpret data analysis results, analyzing trends and changes in performance, and correlation to product or clinical practice changes. 
Initiate proactive performance trend reports, acceptance criteria and safety thresholds. 
Create standardized and custom analysis and reports to communicate overall performance results to business partners, including Quality, Reliability, Clinical and Legal. 
Maintain competency in technical and clinical use of products and clinical environment to provide context for analysis of performance outcomes. 
Choose appropriate software solution for trending and performance reports. 
Collaborate in the development of new systems where applicable. 
Ensure personal understanding of all quality policy/system items that are personally applicable. 
Follow all work/quality procedures to ensure quality system compliance and high quality work. 


please email your resume to kbschennai@kbsconsultants.com