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