Project Statistician

The Project Statistician will support multiple non-clinical development activities including but not limited to the development of statistical methods which can be transferred to product development groups including Toxicology, Clinical, and Operations. The qualified individual will need to develop and maintain good working relationships with multiple functional groups, as well as, gain a working understanding of key subject matter dimensions, especially as they relate to the development of acceptance criteria and statistical decision points. The Essential responsibilities for this position include the following:  developing and validating statistical methods which can be generalized to improve efficiency and rigor across multiple functional groups; translating statistical methods into efficient modules which can be validated and handed off to subject matter experts; developing master study and analysis plans; developing and authoring new procedures and policies; maintaining statistical and scientific competency by staying current with literature and industry trends, especially as they relate to regulatory requirements; and providing training and guidance in the use of appropriate statistical methodology.  The Project Statistician will also assist with the preparation of regulatory documents (such as sBLA and BLA); provide supervision as needed to internal or contract personnel; develop training as appropriate to transfer statistical technology; and provide leadership and stewardship for championing statistical and scientific excellence in all these activities at the Company.  A MS and 8+ years of experience or a PhD and 5+ years experience are required. The successful candidate will be someone who thrives in an environment of high expectations, technical excellence, exemplary professional integrity and ethics.  He/She will also possess:  in depth knowledge of statistical and modeling software including S-plus, R, NONMEM and SAS; in depth knowledge of modeling related to PK/PD and bioassays; exceptional written and verbal skills; the ability to work collaboratively with multiple disciplines and functions; the capability of developing creative approaches to problem solutions; and the ability to handle significant responsibilities with minimum supervision.  An understanding of molecular and cellular biology, pharmacology, toxicology, physiology and pathophysiology is desirable.

Please refer to job code LF6461 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Raritan, NJ
County:	Somerset County
ZIP Code:	08869
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856