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 (, 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 biostatisticians and data managers to identify data issues and generate qu...

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