Principal Biostatistician- Thriving Diagnostic/Biotech

One of the world's leading businesses focused on bringing innovative diagnostic tests and medical devices.

Requirements include:
Providing statistical support for routine projects. Perform data analysis, statistical experimental design, sample size determination, and other appropriate applications of statistical methods in support of product development, clinical studies, manufacturing activities, and product quality. Apply current statistical methods and develop novel methods when necessary.

*Consult and provide guidance on statistical issues to staff, researchers and clients.
*Provide statistical experimental design, data analysis, and data interpretation in support of developmental activities in device and product.
*Conduct data review; write report and present analyses and interpretation to internal customers.
*Support validation, process transfer, process development, process control, product release testing, investigation of non-conformance

*Prior pharmaceutical industry or other regulated environment preferred.
*Strong knowledge in experimental design and data analysis.
*Experienced in standard statistical techniques*Knowledge in: mathematical statistics, nonparametric statistics, applied probability, multivariate analysis, nonlinear regression, generalized linear models, and categorical data analysis, etc.
*Knowledge in algorithms, optimization, simulation, Six Sigma, and survey sampling are desirable.
*Strong working knowledge of SAS or S-plus or R preferred.

*Experience in regulatory submission of class III devices, PMA and/or NDA is a plus.
*Demonstrated ability to work independently and in a multifunctional team environment.
*Strong interpersonal skills.
*Strong reading, oral and written communication skills.To find out more about Real Staffing please visit www.realstaffing.com