Director of Statistics

The Director of Statistics will be responsible for leading and directing the statistical aspects/strategy for one or more therapeutic areas. Each group will consist of six to twelve Ph.D. and M.S. level statisticians who work as a team to provide statistical support to the therapeutic areas. The Director of Statistics is responsible for providing scientific input to project plans, for strategic decision-making on statistical issues pertaining to the plan, and for ensuring that these plans are carried out. This individual will provide expert statistical and scientific recommendations in support of ongoing projects in the Global Project Teams and also be responsible for ensuring that scientific expertise and technologies available are properly integrated to accomplish project goals.  A Ph.D. degree and a minimum of 10 years experience in pharmaceutical development and applied statistics/statistical consulting are required. The qualified candidate must also have experience leading at least two of the following: NDA, BLA, and/or CTD submissions as well as a minimum of 3 years supervisory experience. A high degree of technical competence and communicative ability, both oral and written; a high degree of competence in experimental design, descriptive and inferential statistics, and computer systems, especially in medical applications; pharmaceutical or related industry experience with clinical trials, including interaction with regulatory agencies, especially, FDA; knowledge of the guidelines of worldwide regulatory agencies; and the ability to lead and advise the Global Project Teams and other scientists in the methodology and design of clinical studies are also required.

Please refer to job code LF6010 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Bloomfield, NJ
County:	Essex County
ZIP Code:	07003
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856