*Sr. Biostatistician Willmington, DE 1 Year* *Sr Level Statistics candidate with experience in Designing clinical trails* *REQUIRED ATTRIBUTES: Degree / College Major: Masters or PhD statistician Primary Job Responsibilities and Qualifications: The candidate should have a Masters or, preferably, a PhD in Statistics. The immediate requirements are to be the lead statistician on a large, multi-center outcomes clinical trial. The candidate will contribute to the design and writing of the protocol. This will require independent review of relevant literature. It is expected that the candidate will propose design improvements that will meet clinical and commercial requirements. Developing the study design typically requires developing many scenarios, which require simulations. Knowledge of methods of survival analysis, interim analysis and multiplicity is required. As the protocol is being developed, there will be Advisory Boards with external research groups and Key Opinion Leaders. The candidate would need to be a senior individual that the project team had full confidence in, in order to attend these kinds of meetings. There would likely be an FDA meeting to discuss the protocol, so regulatory experience is desirable. After the study is launched, a Statistical Analysis Plan will need to be developed. The person should be capable of developing detailed analysis plans for primary, secondary and backup analyses. There will also be work with Statistical Programmers developing table templates. The candidate should be able to do hands-on SAS programming, but there should be some part-time support from a lower level statistician and statistical programmer. * *======================== Santhosh [email protected] [email protected] 201-255-0319 Ext 171 / 170 *
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