• BS or MS in Computer Science or related field;
• Five to Seven 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;
• 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.
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.
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