Responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities)
Job Summary
Responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities).
Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan).
Maintain up-to-date advanced knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.
Matching Summary
Responsible for all statistical programming aspects of a large/pivotal study, several studies or project-level activities (incl. submission activities).
Skills & Requirements
Must-have
Advanced SAS experience
CDISC SDTM/ADaM
Statistical programming solutions
Regulatory submissions
Quality control and audit readiness
Nice-to-have
Cross-functional team collaboration
Mentoring other programmers
Subject matter expert
Process improvement initiatives
Key Requirements
BA/BS/MS or international equivalent experience
Experience in a programming role supporting clinical trials