Director, Statistical Programming

About the role

Leads statistical and data management programming for biosimilar studies, building the function's standards, processes and quality frameworks while staying hands-on with programming work.

What you will do

• Set and guide the strategy for programming activities so standards and processes are followed
• Act as senior expert on data standards, programming methods and submission strategies
• Help write and update company standard operating procedures for data management and statistical programming
• Program and oversee SDTM and ADaM datasets, tables, listings, figures and submission-ready packages
• Coach and develop direct reports and support resource forecasts and project allocation

What they look for

• A master's degree or equivalent with at least 15 years of relevant experience
• At least 10 years in statistical programming in the pharmaceutical industry, including leadership and people management
• Extensive life sciences experience and a strong grasp of drug development processes
• Deep knowledge of regulatory requirements for statistical programming, validation and data governance
• Advanced SAS programming expertise