Executive Director, Statistical Programming

Responsibilities

• Lead the Statistical Programming function within the Biometrics Department
• Provide strategic leadership for statistical programming across clinical development projects
• Ensure accountability for programming deliverables supporting clinical analysis and reporting
• Deliver statistical programming and validation support for clinical study reports and other related documents
• Develop and review key documentation such as case report forms and analysis datasets specifications
• Ensure quality of all programming deliverables and maintain relevant SOPs and technical standards
• Manage and oversee third-party service providers and conduct vendor qualifications and audits

Qualifications

• Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field required; Master's preferred
• 14+ years of experience in clinical SAS programming for phase I-IV trials in a pharmaceutical/CRO environment, with 7+ years in a leadership role
• Strong technical knowledge and experience with SDTM, ADaM, and Define.XML necessary
• Advanced proficiency in SAS functionalities including ODS, SQL, MACRO, STAT, GRAPH, ACCESS; familiarity with R Software is a plus
• Strong understanding of regulatory requirements and drug development processes

Benefits

• Comprehensive health, financial, work-life, and well-being offerings for eligible employees and dependents
• Wellness and employee support programs including life insurance and disability coverage
• Retirement plans with employer match and generous paid time off