Software Developer
USA
10 + Years
Job Description
- Define, maintain, design and develop statistical analysis software applications such as SAS, PVCS, R that support client’s business requirements.
- Work with the Statisticians and Data managers to provide SAS programming in analyzing Clinical Trial Data, generating final study reports, tables, listings and graphs.
- Advice the business on best practices in the SAS and different modules while making sure the solution meet the business needs.
- Proactively anticipating the issues in the process and providing resolutions in updating the strategy documents to incorporate the needed updates for SAS metadata consolidation.
- Working on SAS data consolidation project to migrate SAS datasets, catalogs and programs from scattered sources (Cloud storage, windows, Unix NAS storage) to a single Linux server for the ease of use for the business team.
- Involved in preparation, distribution and collaboration of client specific quality documentation on developments across SAS on Unix and Linux landscapes along with regular monitoring on reflecting the modifications or enhancements.
- Building professional relationships with Business clients, management and team members to ensure delivery of proposed solutions, support for critical issues, development of requirements
- Maintain and improve the existing software and performance tune the current processes to help business achieve reliable and faster results.
- Generates and maintains the IT Security access matrix for Statistical applications meeting the business requirements.
- Exposure to CDISC Standards, 21 CFR Part 11, GxP guidelines, HIPAA guidelines and Regulatory Submissions (CSR, BLA, NDA including ISE and ISS).
Degree Requirement: a minimum of bachelor’s degree in computer science, computer information systems, information technology, or a closely related field, or a combination of education and experience equating to the U.S equivalent of a bachelor’s degree in one of the aforementioned subjects.
