Title: Statistical Consultant Order no: PWR6623 Location: Madison - NJ Start Date: 6-Aug-2012 End Date: 3-Feb-2013 Job Description: Candidates MUST be able to complete a 6 month assignment. Extension past that time is unknown. No OT, No Travel required. All work to be performed onsite in Madison, NJ. DESCRIPTION: · The consultant will serve as the Study/Project Biostatistician. The position provides statistical support for protocol development including the sample size calculations, statistical analysis plan (SAP) preparation, statistical analysis of clinical study data and presenting them in the study report, and publications, ensuring that the study design is appropriate, and that appropriate statistical methodologies are used. · As the project biostatistician, the incumbent is also responsible for submission related statistical activities such as generating pooled study analyses for the summary reports. As a senior level statistician, the consultant is expected to be able to work independently with minimum supervision and manage more complex projects. RESPONSIBILITIES: · Utilize statistical knowledge and expertise to provide statistical support for clinical studies, including, but not limited to: Participating in protocol development and ensuring appropriateness of study design, sample size and proposing appropriate statistical methodologies; · Authoring the Statistical Analysis Plan for the protocol; Performing/reviewing statistical analysis, interpreting analyses results, and writing/reviewing the corresponding sections of the clinical study report (CSR); · Overseeing the generation of all statistical appendices; · Reviewing other sections of the CSR as appropriate; · Participating in the process of CRF design and development, ensuring that it meets the protocol criteria and captures all data required to support the planned analysis; · Mock-up, reviewing, and approving tables, listings and graphs specifications; · Actively participate in project/study team meetings; · Establish/negotiate timelines for completion of study related statistical activities. Ensure the study timelines are met; Generates SAP for pooling studies for regulatory submissions and executes them, ensuring that accurate statistical methods are used in the analyses; · Assists with writing and reviewing statistical sections of integrated summary reports; · Plan and coordinate interim analyses, as needed. REQUIREMENTS : · Ph.D. in Statistics or a related field; At least 5 years of pharmaceutical research experience; · Excellent knowledge of statistical methodology and a working knowledge of computer systems; · Strong knowledge in the SAS statistical analysis system is required. · Knowledge of other statistical analysis systems is a plus; · Ability to explain statistical information to non-statisticians; · Knowledge of regulatory requirements governing clinical research.
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