As IT Lead Analyst-Biostat-NJ - The Cambridge Group LTD

Position Description

As IT Lead Analyst-Biostat, you will provide oversight to assigned SAS programmers for the project, both internal and contract. Participate as a member of study management teams and assist in the development of case report forms, data validations, and data quality plans. Lead the development and documentation of mapping specifications for the creation of standard analysis data sets. Act as contact person within biostatistics dealing with data management. Implement report specifications as defined in statistical analysis plans and respond to ad-hoc requests to produce reports for clinical customers (tables, listings and graphs). Design robust, flexible, and modular software for the project. Direct team members in creation of individual components. Oversee integration testing of the entire project software suite. Administer standard validation requirements by: managing code reviews, applying a development-QA-production code development lifecycle, authoring and/or reviewing validation plans and reports. Act as contact person within biostatistics dealing with the exporting of data to the electronic submissions group as well as others dealing with genetics and pharmacoeconomics. Act as contact person within biostatistics with outside companies on data and programming issues. Maintain up-to-date project documentation. Candidates who qualify must possess a B.S./B.A. in computer science, mathematics, statistics or related areas of study. Successful candidate will have in-depth knowledge of SAS programming with at least 5 years of experience in a pharmaceutical industry biostatistics environment. Strong knowledge of SAS Macro. Knowledge of clinical data processing, with emphasis on regulatory agency requirements for data reporting. Understanding of data and system dependencies, experience in integration of studies (ISE and ISS) and validation techniques. High level of accuracy and attention to detail. Ability to work in a team environment and good communication skills. Knowledge of UNIX (including basic shell scripting) and experience leading other programmers a plus.

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