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· Generate the SAS Programming Master Plan for assigned project(s).
· Coordinate project reporting tasks associated with the project.
· Provide input to project timelines, and ensure that project timelines are met for both internal and external clients.
· Ensure that project tasks are completed with superior quality for both internal and external clients.
· Assume responsibility for project SAS Programming budget, and perform monthly time projections for assigned project(s).
· Attend internal team meetings and relevant client team meetings for assigned project(s).
· Coordinate documentation and archival of data, deliverables, and SAS programs for assigned project(s).
· Knowledge and experience in application of statistical methods used in clinical research.
· Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
· Experience with the management and statistical analysis of data obtained from Phase I – IV clinical trials.
· Ability to synthesize results in graphic, oral, and written reports.
· Knowledge of programming and validation methods, and software development life cycle.
· Experience with SAS Base, SAS Stat, SAS Macro, SAS Graph, and ODS as well as strong data step skills.
· Knowledge of relational database concepts, experience with Oracle and SQL.
· Ability to plan long-range needs while assuming responsibility for daily details with a high degree of accuracy.
· Ability to work creatively and independently to carry out assignments of a complex nature.
· Ability to communicate and work effectively and cooperatively with other professional staff members.
· Excellent organizational and program documentation skills, highly detail-oriented.
· Ability to learn new programming languages, new technology, and new tools that will facilitate the clinical trial process.
· BS degree in one of the life sciences, and five years of work experience in SAS programming in clinical environment; or
· BS degree in Statistics, Biostatistics or related field with a minimum of one year of work experience in SAS programming in clinical environment; or
· Masters-level degree in Statistics, Biostatistics or related field with a minimum of one year of work experience in SAS programming in clinical environment
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