Director, Statistical Programming
Core
Lead the Global Submissions group to oversee strategy, planning, and execution of global regulatory submissions across the drug portfolio.
Role type
Senior management leader for statistical programming and regulatory submissions
Builds
Global regulatory submissions and data delivery for drug development programs
Domain
Biotechnology / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Strategic planning, resource allocation, cross-functional leadership, regulatory compliance, process improvement, talent management, budget management, SAS programming expertise
Preferred skills
Strategic change management, compelling communication, network cultivation
Technologies
SAS Base, SAS STAT, SAS GRAPH, SAS MACRO
Responsibilities
Develop operational and sourcing strategies for global submissions, influence global submission planning and timelines, ensure timely execution of statistical programming, identify and drive technical and process improvements, oversee programming standards and procedures, lead talent acquisition and development, manage resources and budgets, stay updated on regulatory requirements
Seniority
Director, strategic leadership and team management