Senior Biostatistician

The Senior Biostatistician will support/participate in the development of clinical program; review protocols and case report forms for soundness of trial design; write statistical methodology section of the protocol; prepare analysis plan and programming specifications; perform inferential analyses; write the statistical section of the clinical trial report and review clinical trial report; support/participate in drug project related activities including preparation of global HA submissions; and oversee CRO deliverables for trials contracted out.  A  PhD and 1-3 years of pharmaceutical experience are required.  The successful candidate will also possess strong statistical and data analysis skills; strong knowledge of statistical and clinical trial methodology; solid hands-on experience as statistician in clinical development program; good knowledge of drug development process, and experience in supporting NDA submissions. Strong ability in protocol development, analyses and clinical trial reports/publications of Phase I-III clinical trials; excellent oral and written communication skills; knowledge of FDA/ICH guidelines; good knowledge of SAS, S-Plus and R computer packages; and good project management skills are also required.

Please refer to job code TV6282 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Livingston, NJ
County:	Essex County
ZIP Code:	07039
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856