Description
Main duties/responsibilities:1. Providing statistical programming and validation support for
clinical study reports, overseeing programming activities by external
vendors (e.g., CROs) when necessary and coordinating programming activities
among the study programmers to achieve timely progress in the following
areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, Integrated
Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE),
electronic submissions and other internal and external requests (e.g.,
publications). Accessing and converting data to SAS from Database
management system and PC file formats (e.g., MS Excel, text files). Working
with external vendors in order to develop or monitor the content and
structure of SAS data sets.
2. Providing input to the Database and CRF Development, creating
edit check programs and providing feedback to the Data Management.
Providing input in developing statistical analysis plans, specifications of
analysis datasets, validation plans, and other related documents.
3. Managing and developing team, maintaining standards for
programming activities, and guiding/coaching Statistical programmers.
4. Working independently to accomplish tasks and goals defined by
supervisor. Attending required training and meetings and bringing in new
ideas to improve the programming process.
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