1 - 5 years
1.0 - 4.0 Lacs P.A.
Hyderabad
Posted:2 months ago| Platform:
Work from Office
Full Time
Statistics Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials. Job Summary Provide statistical programming support to clinical trials. Produce statistical analyses, including generating/validating basic SDTM datasets, safety listings, and safety tables, for clinical trials. Primary Responsibilities Perform assigned statistical programming required for clinical trial analysis and reporting. Work under the direction of senior statistical programmers in completing clinical trial programming tasks. Assist in programming and validation of less complex CDISC SDTM and ADaM datasets. Generate safety listings and tables per protocol, Statistical Analysis Plan. Participate in statistical program validation and quality control activities, as assigned. Apply appropriate statistical methods for data analysis. Develop define.xml and create table of contents of programs for regulatory submissions. Assist in the review of study documents, programs and reports. Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects. Timely completion of assigned tasks. Ensure all programming activities and processes performed are conducted according to SDC s standard procedures and/or sponsor requirements. Adhere to all aspects of the SDC s quality system. Comply with SDC s data integrity business ethics requirements. Perform other related duties incidental to the work described herein. Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Required Skills Sound analytical skills, with the ability to process scientific and medical data. Basic SAS programming skills required, with working knowledge in SAS/BASE and SAS Macros. Exposure in manipu
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