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Biostatistician CT Open (J#45204) Title: Biostatistician Company: Workforce Integration Job Description: At Workforce Integration - Wi? - we know people are the key to successful organizations. So we have concentrated on getting people down to a Science. Ask us Wi? Our client, a top Pharmaceutical company, is seeking a Biostatistician to work in their Ridgefield, CT location. This is a critical role to the company's continued success. Duties will include but not be limited to: Position is responsible for the statistical deliverables and/or exploratory analysis of important clinical development consequence for one or more clinical trials under the guidance and supervision of the Clinical Trial Biostatistician or Clinical Program Biostatistician. Works within a global team and has close interaction with other biostatisticians, statistical programmers, data managers, the Clinical Project Manager (CPM), and the study physician. - Acts as a key supportive biostatistician for 1 or more clinical trials within a clinical project or across multiple clinical projects. - Works very closely, in a supportive role, with the Clinical Trial Biostatistician or Clinical Program Biostatistician. Also works with statistical programmers and other biostatisticians. - Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in the protocol development. Has the opportunity to provide input into the trial design, efficacy and safety parameters and the planned statistical analyses. - Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in responding to the request for the randomization schedule and serves as randomization specialist when randomization schedule is generated internally. Has supervised appropriate interactions with the IVRS vendor. - Provides input in the review of the CRF and other data management related documents. Provides input in the evaluation of the quality of the database. - Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician in the writing of the Statistical Analysis Plan and the mock TFL shells. - Provides input in the preparation of the statistical analyses programs in cooperation with the statistical programmers. Provides input in the validation of selected programs and output of the statistical programmers. - Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician to organize data review and TFL review meeting. Provides input in the review of the clinical trial report and the interpretation of the results. - Assists the Clinical Trial Biostatistician or Clinical Program Biostatistician on the coordination of the statistical activities with CRO statisticians. Communicates accordingly with the CRO. Validates selected statistical output delivered by the CRO. Requirements: - 2 years of experience working as a Biostatistician on Clinical Trials - Must have experience writing data sets, protocols, validating programming (SAS STAT and PROC) - Must have previous experience with clinical trial protocol development, statistical analysis plan preparation, report preparations as the statistician on a clinical trial team. - Must have the proven ability to perform statistical analysis, SAS programming, programming validation, quality control (QC) in the context of clinical trials. - Must have theoretical understanding of the statistical process. - Good verbal and written communications skills are essential. SAS Certification is desired but not absolutely necessary. About the Company: Workforce Integration - Wi? is a WBENC certified Recruiting Firm that specializes in a wide range of solutions and services. Our Staff is recognized as market leaders in successfully staffing major Scientific, Clinical Research, QA & Regulatory Affairs, Engineering, and IT projects. For more than two decades, the professionals at Workforce Integration have advanced the science of staffing. We are experts in developing staffing models which recognize and respond to the complex nature of todays changing workforce and your needs for dynamic workforce opportunities. The Wi? formula combines intensive recruiting, screening and testing procedures, with the variables of your individual needs such as Contract or Direct Hire placement; and match that with continuously evolving skill-set requirements & specializations. The final solution blends all of these factors with marketplace demands for innovation, proven performance and the most current expertise to achieve Workforce Integration.

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