Hotline: 678-408-1354

Clinical SAS/SDTM Programmers

Job Description:
Job Responsibilities:
Develop and validate SAS programs to produce high-quality deliverables within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, tables, listings and figures.

Review and provide feedback on deliverables from other clinical groups, including but not limited to statistical analysis plans; table, listing, and figure shells; data management plans; data transfer plans; Safety Report Specification; electronic data entry screens; and case report forms.

Clear and proactive communication with Study and Project teams to clarify requirements and specifications, update on assignment status and convey data irregularities.

Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.

Ensure the edit check specification and data quality for ongoing clinical study.

Keep abreast of SAS enhancements and supports achievement of major reporting deliverables and milestone .

Manage database transfer process and database specifications in collaboration with outside vendors for the purpose of providing in-house data management and analysis. Provide active support on initiatives that facilitate infrastructure and process enhancements within Biometrics

Job Requirements:
CDISC standards in the development of SDTM and ADaM datasets

4+ years’ experience in SAS programming in the pharmaceutical industry

Experience in generating TLFs (Tables, Listings and Figures)

Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT Package/define.xml development and SDTM data transfer operations on clinical studies

Experience in both production and/or QC programming of SDTM datasets, analysis datasets, tables, listings and figures, for multiple clinical trials

Expertise in CDISC implementation, particularly SDTM/ADaM datasets, define.xml and specifications

Experience in NDA submissions and FDA regulations

Good knowledge of clinical trial study design and electronic data submission requirements

Contact Us

Eltas EnterPrises Inc.
3978 Windgrove Crossing
Suite 200A
Suwanee, Georgia
30024, USA
contact@eltasjobs.com

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