Senior Biostatistician

The Senior Biostatistician/Manager Biostatistics will provide consultation services to the Clinical Project Leader on study design issues and develop statistical methods section of the protocol. He/She will develop tables of content and templates for reporting study data and results to meet regulatory standards; and perform statistical analysis of study data with particular emphasis on efficacy/outcome data. The successful individual will also provide specifications to programmers for generation of SAS analysis datasets for both efficacy and safety analyses; perform validation of key statistical results and provide expertise to protocol development and experimental design, analysis, and reporting.  The essential functions of this position include:  preparing detailed Statistical Analysis Plan (SAP) to meet regulatory standards; reviewing study protocols, CRFs, and other study-related documents in order to ensure correctness of statistical representation of data and results, and collection of required data; producing table templates for reporting of study results and data; and coordinating data and table review activities among the project team members.  Additional key responsibilities include:  providing input in preparation of study reports, with particular emphasis on the statistical methods section, and working closely with Medical Writing in study report preparation; responding to questions from the FDA and other regulatory authorities on statistical issues; developing templates for ISS and ISE statistical tables for NDA submission in conjunction with clinical, and providing specs and supervision for production of ISS and ISE tables; reviewing ISS and ISE reports towards NDA submission; performing statistical analysis for publication, and providing specifications to programming for generating analysis data sets. A PhD in Statistics/Biostatistics and 2 years of experience in Phase II/III clinical trials are required.  The qualified candidate must also possess:  an understanding of the company's products, the competition, and the pharmaceutical industry in general; a current awareness of new drug developments in the business; in-depth knowledge of statistical principles, applications and SAS programming software; and knowledge of current industry and regulatory submission practices, protocol designs, and terminology.

Please refer to job code LF6701 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Gaithersburg, MD
County:	Montgomery County
ZIP Code:	20877
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856