Clinical SAS Programmer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Durham, North Carolina

Post: Wed, 22 Mar 2023 06:31:53 GMT

Expires: Wed, 19 Apr 2023 23:59:59 GMT

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—————————— Job Description ——————————

Requirements:

Minimum of 5+ years of statistical programming experience in the pharmaceutical/biotech industries

Experience in BLA, NDA/sNDA and EMA submissions.

Knowledge and experience working with CDISC Standards (expertise in both SDTM/ADaM)

Demonstrated ability performing all levels of programming activities for a clinical project.

Experience working in the Cardiovascular therapeutic area is preferred.

Responsibilities:

Perform data manipulation, analysis and reporting of primarily clinical trial data.

Program and generate tables, listings, and graphs (TLGs)

Participate in the review of statistical analysis plans, table specification, develop specification for SDTM and ADaM data sets.

Review, and comment on CRFs, annotated CRFs, and edit checks and related documents.

Create SDTM and ADaM Datasets and related documentation.

Fulfill ad-hoc programming requests.

Other duties as needed.