Principal Programmer Analyst
Core
Lead statistical programming for complex clinical studies, developing and validating analysis packages to support drug development and regulatory submissions.
Role type
Principal IC clinical programmer analyst
Builds
Statistical analysis packages and reports for pivotal clinical trials
Domain
Biopharmaceuticals / Clinical Development
Required skills
Statistical programming, R, CDISC standards, Good Programming Practices, regulatory compliance (FDA/EMA), clinical trial design, data governance, mentoring
Preferred skills
AI/ML application, strategic technical planning, cross-functional collaboration, innovation in programming workflows
Technologies
R, CDISC standards
Responsibilities
Lead programming activities for one or more studies; ensure adherence to Good Programming Practices and CDISC; mentor junior programmers; support regulatory interactions; identify gaps and implement innovative solutions; establish governance frameworks.
Seniority
Principal, hands-on IC with mentorship