Associate Director, Biostatistics

The Associate Director, Biostatistics will review protocol and prepare statistical sections, including sample size calculation; review CRF, database design, and edit check specs; prepare detailed statistical analysis plan, including derived dataset specifications and table/listing shells; work closely with Statistical Programmers in test runs, identify data quality issues for key efficacy and safety variables, and work closely with Statistical Programmers in the final statistical analyses, including results interpretation. Additional essential responsibilities include:  reviewing final study report and preparing statistical methods sections; providing statistical leadership for the Biostatistics, Statistical programming, and Data Management study team; and providing statistical support to new drug in-licensing, development, submission, approval, and marketing; performing other ad-hoc statistical activities as needed; mentoring senior statisticians; and participating in establishing standard operating procedures and working practices for Biostatistics department.  A  PhD and 6-8 years of experience are required.  The successful candidate must also possess:  good knowledge of SAS computer package; excellent communication skills (verbal and written) and interpersonal skills; outstanding project management skills; and expert knowledge of clinical trial methodologies and regulatory guidelines.

Please refer to job code LF6357 when responding to this ad.

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