*SAS Programmer*
*Woodcliff, NJ*
*12 months +*
*Phone & In-person*
*$55-60/hr*
*Responsibilities*
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.
*Qualifications*
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 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.
*Thanks and Regards*
*Shweta Ojha*
Technical Recruiter | Sage Group Consulting
*Direct: *732-784-6492
*Email: *[email protected]
*Gtalk: *sojha1290*|Ymail: *ojha1290
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