Statistician -Early Clinical Development

Located in the department of Biomathematics, the Senior Biostatistician will provide high level statistical support to drug projects in the clinical research early development phases within one or several therapeutic areas. On project level teams, the Senior Biostatistician will engage in strategic discussions regarding the early clinical development of a compound even before entry into man and contribute to clinical development plans. The successful candidate will also be responsible for the following:  early clinical development studies (entry into human studies, experimental medicine studies, PoC/PoM studies, etc) as well as all clinical pharmacology studies during the life cycle of the compound;  close collaboration with Statistical programmers and other statisticians while leading the efforts to ensure that the results of statistical and other analyses are of high quality and available in time to support decision making of the project teams; advising teams on the correct interpretation of data from various types of experiments; contributing to the writing of protocols as well as clinical study reports; participating in health authority interactions during the early phases of drug development; and contributing to the development of innovative study designs and new techniques for data analyses.  A MS or PhD and 3 years experience are required.  The qualified applicant will also possess proven experience in statistical data analyses in the life sciences and in communicating statistical principles to non-statisticians; experience using statistical software (SAS or S-Plus/R); the ability to communicate clearly and effectively in written reports, data presentations and meetings as required; and fluency in both written and spoken English.  Strong analytical skills and practical experience in a wide variety of statistical methodologies are also required. Several years of experience working as a statistician in early or late phases of clinical drug development in a pharmaceutical environment; strong and proven interest in the application and development of new statistical methodologies; experience in practical applications of Bayesian Statistics or adaptive designs; and experience in working in an interdisciplinary and international environment are all preferred.

Please refer to job code LF6280 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Passaic, NJ
County:	Passaic County
ZIP Code:	07055
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856