Senior Programmer

This person will be responsible for programming function for all phases of clinical development. The senior programmer will lead the development and maintenance of analysis programs to support clinical projects / programs. He / she develops standard programming procedures and troubleshoots as required for staff regarding specific programming concerns. The Senior Programmer assists with the continual process development within the data management group.

Essential Duties and Responsibilities:

- Review database design specifications;
- Review CRF content vs. global object library to ensure consistency and standardization within the database;
- Assists in the development of CRF and validation specifications;
- Assists in performing validation procedure testing;
- Write and validate programs using the SAS system to develop tables, graphs and listings to be incorporated into submissions to regulatory agencies;
- Perform independent QC of SAS programs;
- Extensive use of Proc Report
- Develop systems for data entry and data review that comply with all relevant regulations;
- Help define appropriate summaries and data presentations for internal and external use. Responsible for validation and quality assurance of any output produced for specific projects;
- Develop systems for identifying error in clinical databases caused by improper data entry, protocol noncompliance and transcription error (i.e., edit checks and exception reports);
- Provides technical assistance and training to programming and non-programming personnel;
- Develops solutions to basic problems and assists in the development of new technologies;
- Maintains all required study documentation; Attends study management meetings as necessary.

Knowledge and Skills Required:

EDUCATION:
- BA / BS computer science or information technology
- Extensive knowledge of SAS, SQL and other programming languages.

EXPERIENCE:
- 5 years programming experience in the device / pharmaceutical / CRO industry
- Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission is required
- Oracle Clinical and Clintrial database experience a plus

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=500624-3-683