Job Description
Responsibilities:
- Provides SAS programming support to all clinical studies.
- Manages assigned programming CROs providing oversight and appropriate QC for programming deliverables.
- Provide statistical programming support for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD).
- Provides primary programming and QC support for any internally produced outputs.
- Reviews and approves SAS programming instructions and CDISC/ADaM specifications.
- Performs statistical analysis and simulations using SAS to support clinical trial design and data interpretation.
- Reviews and provides input on eCRF design, external vendor data specifications, edit checks, and other Data Management related documents to ensure appropriate data collection for statistical programming.
- Works closely with biostatist...
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