Description
Main purpose of the job:To support the Biostatistics team by carrying out and overseeing
programming activities of statistical programmers and external vendors (as
required), and to ensure timely and accurate programming and validation
activities for clinical studies. Contributes to the overall efficiency and
best practice of the Biostatistics group, demonstrating the ability
to work efficiently and to a high standard within a clinical team
environment.
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.
To find out more about Real please visit www.realstaffing.com