Sr Principal Analyst, Statistical Programming
Core
Lead and oversee statistical programming activities across clinical studies and programs, ensuring compliance with regulatory standards and driving data strategy.
Role type
Senior Principal Analyst, Statistical Programming (Management)
Builds
Regulatory submission deliverables (eSub components, define.xml, annotated CRFs, reviewer guides, transport files) and ADaM specifications
Domain
Pharmaceutical/Biotechnology clinical trials and regulatory submissions
Required skills
SAS programming (Base, STAT, Macro, Graph), CDISC standards (SDTM, ADaM), clinical trial lifecycle management, regulatory submission requirements (ICH, FDA, EMA), vendor management, project leadership
Preferred skills
R programming, ISS/ISE development, NDA/BLA submissions experience
Technologies
SAS, UNIX/Linux, eSub
Responsibilities
Lead statistical programming activities across studies/programs; Manage programming deliverables from database build through regulatory submission; Partner with cross-functional stakeholders to communicate requirements and risks; Develop ADaM specifications and collaborate with Biostatistics; Identify opportunities to improve programming processes and standards
Seniority
Principal, Management
