Job Listing: e-submission SAS Programmer

Volt is partnering with one of the world's foremost biotechnology companies. We are currently recruiting for a long term contract e-submission SAS Programmer.

Purpose of Role:
To perform the preparation, readiness and quality control of submission deliverables for the dataset section of regulatory submissions conducted by the client and its affiliates, according to Good Clinical Practice (GCP) and department Standard Operating Procedures (SOPs).

Job Responsibilities:
1. Ensure published CRT deliverables are in compliance with regulatory agency electronic submission guidance.

2. Work with project teams to provide regulatory electronic submission guidance knowledge related to the requirements for dataset submission deliverables.

3. Follow submission preparation tasks to ensure high quality deliverables that comply with regulatory electronic submission guidance:
a. Creation and QC of data definition tables.
b. Tracking of all variables in submission datasets as to their source in either annotated case report form, external non-CRF data documentation, common variables documentation, or analysis dataset documentation.
c. Documentation of all datasets including algorithms for derived variables, description and purpose of datasets, common variables, retained variables etc.
d. CDISC SDTM implementation in submission datasets.
e. QC of datasets and programs posted by the SAS Programming group, against table, listing and figure content in corresponding CSR and CRF sections to ensure that submission dataset section supports other clinical submission sections.
f. Support implementation of data standardization within project teams.
g. Use standard SAS programs or write ad hoc SAS programs for creating, checking submission content.

4. Work with CROs and vendors to ensure that final deliverables for dataset section of deliverables will be compliant with regulatory agency electronic submission guidance when they are preparing for submission, and to ensure that dataset deliverables will not cause submission issues when CDDS is doing the publishing.

5. Investigate, evaluate and propose the use of emerging publishing technologies for use in preparation of dataset section of submission.

Volt Services Group offers competitive compensation and benefits, a staff who are focused on the quality of your career and goals and the solid security of a company trusted by Fortune 500 companies for over 50 years. Volt has over 300 company-owned & operated locations, a National & global presence, and recruitment efforts in every state. Providing people, knowledge & technology to over 10,000 customer companies from small to large. 60% of the Fortune 100 and 50% of the Fortune 500.