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.
- BS or MS in Computer Science or related field;
- 5-7 years of strong experience in programming with clinical trial data and developing programs, testing, and documentation;
- Strong SAS programming skills required in Windows and UNIX environment, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SQL;
- Extensive experience of handling SDTM mapping, related data structures, and programming to create SDTM data sets;
- Extensive experience in SDTM validation using OpenCDisc.
- Good knowledge in developing Define.xml and its validation.
- Extensive experience of handling external data, e.g., laboratory data, PK, ECG, Biomarker, Imaging, etc.
- Good understanding of standards specific to clinical trials, such as CDISC, SDTM, MedDRA, WHO DRUG;
- Good understanding of relational databases, e.g., ORACLE; Knowledge of the EDC System, InForm and underlying data structure is a plus;
- Knowledge of using JReview/IReview is a plus;
Best Regards
Mohit Garg
Integrated resources Inc | Team Recruitment | 732-429-1634
