Clinical SAS Programmer
Posted on :
12-11-2022
Employer Active
1 Vacancy
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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
- 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.
Employment Type
Full Time
Key Skills
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