US-MA-Rockville: Senior Biostatistician

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Date: 26-Aug-2008

Senior Biostatistician

Job Responsibilities: • Provide statistical expertise to the design, conduct and reporting of our clinical development programs and trials. • Ensure the integrity of data sets and statistical analyses for clinical trials and subsequent regulatory submissions. • Be involved in the selection of data management and statistical CRO's. • Evaluate quality of databases and statistical analysis programs provided by CRO's. • Provide management oversight of contractors engaged to handle the data management and statistical analysis of the Company's clinical trials and pharmacovigilance safety database. • Provide statistical analyses of safety database for Medical Affairs and Pharmacovigilance. • Represent the company as the statistical expert at meetings with regulatory authorities and others. • Provide statistical support to the Process Development Group as needed. • Undertake statistical analyses for product stability programs run by Quality Control. • Ensure an appropriate level of statistical understanding across the team. • Maintain expertise in state-of-the-art data manipulation and statistical analyses. • Create and maintain a network with key decision makers, particularly in regulatory authorities.

The right individual needs a higher qualification with 5-10+ years experience in the pharmaceutical (preferably biopharmaceutical) industry. The hired professional will ideally have worked across clinical, pre-clinical and non-clinical areas of the industry and have had significant interactions with regulatory agencies both in the US and elsewhere. Candidates must be able to demonstrate expertise in statistical methodology, software and computer systems. Additionally, the hired individual will need to exemplify strong communication and collaboration skills, be a strong team player, have the ability and flexibility to prioritize between multiple fast moving projects and be willing to play a full part in building the capabilities of an already excellent team.

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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/