- Strong understanding of clinical trial processes pertaining to clinical data reporting and management.
- Excellent knowledge of various modules of SAS including but not limited to SAS/STAT, SAS/Graph.
- Understanding and experience with SAS/Connect, SAS/Access.
- Experience of working with various versions of SAS including SAS-8.2, and SAS-9.
- Expertise in Develop mapping specifications for CDISC SDTM data mapping and create Analysis metadata Specifications as per the requirements.
- To work extensively on generating System Level/Broad Use macros for CDISC Compliant ADaMs and TLF's.
- Worked on ISS/ISE and DSUR Reporting.
- Perform compliance checks on SDTM models using Open CDISC validator tool.
- Experience of working in clinical reporting is strongly preferred.
- Knowledge of various phases of clinical trials, safety domains and clinical reporting process. Knowledge of ICH-GCP guidelines and regulations such as 21 CFR Part 11.
- SAS Certification is a big plus.
- Good communication skills.
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SAS Clinical Programmers - Newark, United States - IT Elite Inc
Description
Required Skills:
-• years of experience in statistical programming.
Following technical skills required/desired:
Microsoft Office and Knowledge of Database systems.