Associate Director of Biostatistics

The Associate Director of Biostatistics will be responsible for providing statistical support for designated therapeutic areas within the Medical Organization. He/she will be responsible for providing direction and statistical oversight in the entire product development cycle, focusing on Phase I-III clinical trials. The major duties and responsibilities (in addition to supervising others) include:  participating in the design, conduct, analysis, and interpretation of clinical studies and research projects; possibly performing as project statistician for some projects; applying statistical techniques to facilitate better decision-making and improve business operation; supporting the preparation of regulatory submissions and interactions with regulatory agencies; regularly interacting with senior management and executive levels in strategy meetings; contributing to strategic planning to ensure statistically optimized clinical development plans and assisting in the creation of strategic objectives for regulatory filings; and participating in mentoring and training employees in the use of these technologies/methodologies.  Additional essential functions of this position include:  participating in planning and carrying out organization development and professional growth of staff statisticians; collaborating with other statisticians in improving and sharing statistical approaches; managing and planning Biostatics resources and coordinating statistical efforts with outside organizations, CROs, and consultants; collaborating with colleagues from other departments within the Medical Organization to achieve departmental and corporate goals; participating in establishing SOPs and guidelines within the Medical Organization as well as furthering the development of SOPs and other controlled documents within the Biostatistics department; performing performance evaluation of direct reports and coordinating with other senior Biostatistics staff to insure consistency among statisticians; and managing staff in hiring and discipline.  A MS or PhD and a minimum of 5 years of Biotech or Pharmaceutical industry experience and 2 years of management experience are required.  The successful candidate must also possess: comprehensive knowledge of applied statistical principles and modeling in the design and analysis of clinical studies and proficiency in statistical software such as SAS and StatXact; excellent interpersonal and organizational skills along with effective oral and written communication skills; successful management experience; experience in departmental SOP and process development improvements; comprehensive knowledge of SAS programming, data management, and regulatory guidelines; and experience in regulatory interactions and submissions.

Please refer to job code LF6668 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Germantown, MD
County:	Montgomery County
ZIP Code:	20874
Pay Rate:	Open
Job Terms:	full time
Company:	The Cambridge Group Ltd.
Phone:	E-mail or fax only
Fax:	203-226-3856