Senior Clinical Data Programming Lead Jobs

Strong written and oral communication skills, and project management skills

Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.

At least some relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.

Good understanding of ICH and Regulatory Guidelines including submission requirements and data conformance (e.g., Pinnacle21)

Statistical Programming and SAS, R, or Python hands-on experience

Working knowledge of clinical data and relevant data standards (e.g., CDISC)

Build SDTM data set specifications based on study requirements

Develop data programming specifications for study requirements

Execute programs and generate clinical data outputs according to study/client requirements

4+ years of experience in clinical data programming and delivery

Experience in building SDTM data set specifications and annotating CRFs

Strong multitasking skills and ability to meet timelines