Principal Biostatistician

The Principal Biostatistician will work with pharmaceutical scientists in the design and analyses of stability studies, method validation experiments, defining manufacturing design spaces and analyses of process analytic data. He/She will train scientists in use of software to analyze & visualize experimental data; validation of new assays, and analysis of data generated by process analytic technologies. Additional essential functions of this position include:  designing experiments, preparing reports, clearly communicating the results to stakeholders in non technical language; developing visualization techniques that can be used by scientists to interpret experimental & process analytic data; keeping abreast of tech regulatory developments; and assisting in responses to FDA & foreign health authorities.  A MS and 4 years experience or a PhD and 2 years experience are required.  The qualified candidates will possess the following:  expert knowledge of DoE, multivariate statistics, general linear models & mixed models; excellent written and oral communication skills; proficiency with SAS, S Plus and or JMP; familiarity with relational data bases, MS Excel & Visual Basic;  an understanding of regulatory stability guidelines, and good manufacturing practices regulations and ICH guidance.  Experience in designing supporting stability studies, quality by design, and process analytic technologies determining design space are all highly desired.

Please refer to job code LF6790 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Lawrenceville, NJ
County:	County
ZIP Code:
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856