Clinical SAS Programmer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : South Plainfield, New Jersey

Post: Thu, 23 Mar 2023 06:34:35 GMT

Expires: Thu, 20 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Responsibilities:

Independently develop/validate programs that generate analysis datasets based on ADaM specifications.

Prepare/QC ADaM datasets documentation: Define.xml, Reviewer’s Guide and analysis metadata report.

Independently develop/validate programs that generate tables, listings and graphs specified in the protocol or the Statistical Analysis Plan (SAP) including efficacy statistical analysis.

Perform quality control on final reports.

Provide QC and validation reports.

Support development of technical programming specifications for ADaM standards

Communicate with programming and statistics leads, data managers and other team members.

Provide project progress updates of programming activities.

Requirements:

At least 8 years of experience in the pharmaceutical industry

Principal level SAS programming skills with experience programming efficacy datasets and outputs

Experience with creating PK datasets and outputs (ADPC and ADPP), generating datasets for PK analysis a plus.

Good knowledge of industry standards including CDISC data structures (SDTM and ADaM)

Understanding of the drug development process (Phase 1 – 4)

Experience in CNS preferred, Nephrology is a plus.

Experience in reviewing CRF, SAP, output mock shells and Protocols from programming perspective.

Experience in developing CDISC compliant ADaM specifications.

Experience leading study is a plus.

Experience in working with Adhoc requests.

Experience in validating ADaMs and TFLs

Strong knowledge on SAS macros and able to work on modifying/existing SAS programs.