Contractor - Statistical Programmer

Perform programming support for the statistical analysis and database management.

RESPONSIBILITIES

1. Creation of SAS programs to Develop or Validate SDTM/ADaM/TLFs.
2. Provide oversight for CRO SDTM/ADaM/TLFs deliverables for multiple studies.
3. Generate/review SDTM mapping specifications, annotated CRFs, ADaM specifications for inhouse and outsourced studies.
4. Define. XML files and reviewer’s guides using standard tools/templates per CDISC and FDA guidelines.
5. Support responses to health authority information requests, publications, ad-hoc analysis.

REQUIREMENTS

1. BS or MS in Computer Science or Biostatistics or equivalent industry experience.
2. 5 years of industry experience in SAS programming to include: SDTM, ADaM and TLF.
3. Expertise in SAS language, procedures, and options including Macro language, BASE SAS, SAS/STAT , SAS Macro and SAS/GRAPH.
4. Good knowledge of 21CFR11 and GCP.
5. 2+ years of oversight experience for a CRO is preferred.
6. 5 years of review/generating SDTM mapping specifications, annotated CRFs and ADaM specifications.
7. 5 years of CDISC and FDA standards knowledge.
8. 5 years of experience in generating Define.XML and Reviewer’s Guides.
9. Creation of all files, documents, and analyses necessary to support electronic submission(s) in an eCTD format, including ISS/ISE.
10. This is a hybrid role. Must live a commutable distance to our corporate headquarters in Florham Park, NJ.