Clinical SAS Programmer Job at Katalyst Healthcares & Life Sciences
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.
- 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.
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