SAS Programmer
Novella Clinical - Durham, NC

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Develop and validate SAS programs to perform data presentation and analysis. Provide programming support to project team members and other SAS programmers.

• Lead SAS Programmer on one or more project teams:
? 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).
• CDPS Development:
? Gather sponsor requirements, and develop or review clinical data file (CDF) specifications.
? Write or review CDF test data specifications, and coordinate the data entry effort.
? Program and unit-test CDF datasets, including integration with coding system.
? Perform scheduled data transfers.
• Integration and reconciliation of data transfers:
? Work with vendor to define specifications for transfer of data from vendor to PharmaLink.
? Program and unit-test back-end integration of external data, and reconciliation reports.
? Program and unit-test creation of file(s) compatible with CDPS import utility, for import of data to CDPS.
• Statistical analyses, summaries and reports:
? Review and provide comment on summary and analysis plans.
? Develop and/or validate analysis datasets and tables/listings/figures.
• Aggregate data checks and other data review activity:
? Review specifications for data management’s planned aggregate data checks.
? Program and/or validate aggregate data checks, data review listings, and any other SAS-based data review reports for project team use.
? Set up project-specific I-Review system, including standard and custom views.
• InfoLink and Site Payment systems:
? Write or coordinate development of test data specifications, and coordinate data entry effort.
? Set up standard reports; program and/or validate study-specific criteria for standard repots.
? Develop and/or validate custom reports.
• Other reporting development:
? Write or coordinate development of test data specifications, and coordinate data entry effort.
? Develop and/or validate programs to generate reports.
• Perform independent code review, and develop test plans, as needed for SAS programming activities.
• Perform other duties as assigned.

• Knowledge of clinical research process and methodology.
• Understanding of current GCP, ICH, and FDA guidelines and regulations applicable to conduct of clinical research.
• Knowledge of programming and validation methods, and software development 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.

• Degree requirements include one of the following:
? High school diploma (or equivalent) with a minimum of four years work experience in programming, including two years SAS programming work experience; or
? Associate degree, with a minimum of three years work experience in programming, including one year SAS programming work experience; or
? BS degree, with a minimum of two years of work experience in programming, including one year SAS programming work experience.

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