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Professional Responsibilities:- Represent the Statistical Programming team in Clinical Study Team meeting to address deliverables and timelines with the focus on data integrity and collaboration.
- Develop, test, and validate SAS programs to produce and maintain CDISC-compliant, submission-ready SDTM, ADaM and TFLs.
- Work cross-functionally with Statisticians, Data Managers, Clinical Operations, Medical Monitors and Medical Writing to manage programming related deliverables.
- Review and support the development of study-related documents produced by other functions, e.g. SAP, Protocol, Case Report Form, Data Management Plan, database specifications, EDC data structures, DMC plans and other clinical documents.
- Monitor and evaluate ongoing clinical trial data and contribute to the resolution of data discrepancies. Develop necessary tools to improve programming efficiency and facilitate review of clinical trial data.
- Support the development of integrated summaries (ISE/ISS), CSR, conferences/publications, ad-hoc analyses, and regulatory deliverables.
- Ensure proper filing of study documentation, regulatory compliance, and inspection readiness.
Education/Experience:
- Bachelors or Master’s degree, in Statistics, Mathematics, Computer Sciences, Life Sciences or other relevant scientific subject, or equivalent related experience.
- 15+ years’ clinical research and development programming experience using SAS
Professional Requirements:
- Solid knowledge of Base SAS, SAS Macro language, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS
- Extensive oncology experience.
- Experience editing preexisting ADaM specifications.