Job Description

The Statistical Programming Contractor supports statistical programming activities in the production of the analysis datasets, tables, listings, figures, electronic submission components, and complex ad hoc analyses. Depending on experience level, may lead a study.

Responsibilities:

• Does both production and QC programming of SDTM datasets, analysis datasets, tables, listings, and figures, for multiple clinical trials using SAS software.
• Ensures standards at a drug program level; integrates data across multiple studies or drug programs.
• Works with minimal supervision under the direction of a lead programmer.
• Communicates issues to lead programmer or manager.
• Must meet timelines or communicate proactively and effectively if timelines are at risk so that plans can be adjusted.
• Expected to contribute to departmental process improvement initiatives.

General Knowledge and Skills:

• Able to handle a moderate to large volume of complex tasks with minimal supervision.
• Able to handle ad-hoc requests with minimal guidance.
• Recognizes when negotiating skills are needed and seeks assistance when necessary.
• Excellent organizational, interpersonal, and communication skills.
Minimum Educational and Experience Requirements:
• Bachelor s degree or equivalent, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• Previous SAS programming experience, including SAS STAT, GRAPH and MACRO.
• Previous relevant pharmaceutical/biotech industry experience.
• Extensive knowledge of drug development process and clinical trials.
• Extensive knowledge of drug submission requirements, relevant ICH and FDA/EMEA guidelines, CDISC standards.
• Open to all levels ranging from 3 to 10 years of pharmaceutical/biotech industry experience

Location: http:///VyImsr