Senior Biostatistician

Senior Biostatistician

Job ID: 20305 # Positions: 1 Location: US-NJ-Raritan Experience (Years): .. Posted Date: 4/7/2009 Recruiter: Lei Wang

Apply for this job: Your application choices are: * Apply for this jobonline * Send your resume as an attachment viae-mail * Refer someone you know More information about this job: Responsibilities: *  Determine the statistical methods and models used to analyze the results of performance evaluations and, when necessary, defend those methods to the relevant regulatory agency. * Serve as consultant in experimental design and scope, sample size determinations and methods of analyses. * Prepare, document, and validate computer programs for the statistical analysis of pre-clinical and clinical study data. Review program output to assist in statistical analysis and interpretation of data. * Develop computer programs and methods to determine and ensure the completeness and accuracy of all databases. * Prepare/review/approve project study protocols, statistical analysis plans, case report form designs, database and analysis dataset specifications, clinical study reports and analyses submitted to regulatory agencies. * Interact with, and review statistical work provided by outside vendors (Contract Research Organizations (CROs), independent contractors). Assist in CRO capability assessments, when called upon. * Ability to effectively choose statistical methodology for analysis of clinical trial and pre-clinical research data (as the choice of analysis is critical and may affect the submission to a regulatory body, such as the FDA).

Qualifications:

M.S. in Statistics,at a minimum;PhD (Biostatistics/Statistics) PREFERRED;A minimum of three years of industry experience. Two to three years experience in the Diagnostics industry is highly desired, but may be substituted with similar experience at a pharmaceutical company or CRO. Strong technical background in one of the biological sciences.  Other specific requirements include: Experience in analyzing pre-clinical data, design of experiment and random effects model. Practical expertise in parametric and non-parametric statistical methods. Thorough knowledge of SAS Base, Stat, Graph, QC and SAS Programming skills, such as data manipulation, SAS Macro programming, and SAS/IML. Ability to write clearly and concisely, and to communicate simple, as well as complex statistical concepts and results to non-statisticians. Ability to work within a cross- functional team environment. Knowledge of FDA guidelines. Ability to work on multiple simultaneous assignments in an atmosphere of changing priorities. Skilled with PC based word processing and spreadsheet software, such as Microsoft Word and Excel, respectively.

Please refer to job code comrise-20305 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Biostatistics
Location:	Raritan, NJ
County:	Somerset County
ZIP Code:	08869
Pay Rate:	Open
Job Terms:	full time
Company:	Comrise
Phone:	email only please
Fax:	email only please