Sr SAS Programmer Analyst - SDTM
- Responsible for SDTM data creation and delivery for oncology studies.
- Prepare SDTM Mapping specification following company standards.
- Create or participate in SDTM annotation for CRFs/eCRFs for oncology trials.
- Develop programs to create SDTM datasets and Define.xml for statistical analysis, tables & listings, and regulatory submissions.
- Perform Open CDISC validation, coordinate to resolve issues, prepare associated documentation
- Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by the Oncology Data Management and other areas of Clinical for data review.
- Ensure all programming activities and processes performed are conducted according to standard operating procedures, good programming practices, and GCP guidelines.
- Strong problem-solving skills;
- Able to work independently and as a team player; Good organizational, time management, and project management skills ;
- Capable of communicating technical concepts
- Good understanding of system development life cycles, GCP, and related Regulatory guidelines.
- Should be able to manage the assigned projects independently with minimum supervision.