I have another excellent long term opportunity available with my client at North Jersey, NJ
We are seeking a strong SAS Programmer Analyst with very strong proven hands-on experience in SDTM-In the areas of Mapping, Related Data Structures, validation utilizing OpenCDisc and programming. This is an ON-SITE role. The candidate MUST have the ability to interview on-site with the client after a phone screen is completed. The full details are below. If you have any questions about the project after you have read my information below, please feel free to contact me.
Title-SAS Programmer Analyst-SDTM Experience
Location-Northern, NJ-
Duration-at least 12 Months
Rate- The client is flexible, an average rate
Work Eligibility -Corp. to Corp. candidates can be considered for this role.
The experience with SDTM is very important to this role, and a candidate without this type of hands-on experience cannot be considered.
SAS Programmer Analyst - SDTM
Daily 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
Chandu.A
chandu@sun-itsolutions.com
904-737-2046 ext: 154
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