Senior Director Evidence Delivery

Role Summary

The Senior Director, Evidence Delivery leads a global organization responsible for transforming clinical data into high-quality, actionable evidence across the clinical development portfolio. This role drives the strategy, innovation, and operational excellence behind submission-ready datasets, analyses, and visualizations that support regulatory, market access, and publication needs. The Senior Director champions modernization through open-source programming, advanced analytics, automation, and AI/ML. Reporting within SPDDS and QSDO, this leader ensures regulatory compliance, inspection readiness, and continuous improvement while building a future-ready evidence delivery organization.

Responsibilities

• Define and execute the global Evidence Delivery strategy aligned with clinical development and regulatory objectives
• Lead delivery of high-quality, submission-ready datasets, analyses, and visualizations
• Drive adoption of open-source programming platforms such as R and Python
• Champion AI/ML, automation, and advanced analytics to improve efficiency and scalability
• Establish reproducibility, transparency, and traceability frameworks for evidence generation
• Ensure compliance with SOPs, GCP, CDISC standards, and regulatory requirements
• Lead modernization initiatives including cloud computing and workflow automation
• Partner cross-functionally with Statistics, CDM, Regulatory, Safety, Digital, and Market Access teams
• Build, mentor, and retain a high-performing global evidence delivery organization
• Represent Evidence Delivery in audits, inspections, and external industry forums

Qualifications

• Required: Advanced degree in Statistics, Data Science, Computer Science, or related field
• Required: 15+ years experience in biotech, pharma, CRO, or clinical development environments
• Required: Senior leadership experience in evidence generation or statistical programming
• Required: Deep expertise in SAS and strong knowledge of CDISC standards
• Required: Strong understanding of clinical trial processes and regulatory requirements
• Required: Proven success leading teams in regulated environments
• Required: Experience implementing automation and advanced analytics solutions
• Required: Exceptional stakeholder engagement and communication skills
• Preferred: Experience applying AI/ML in clinical evidence workflows
• Preferred: Management of external service providers and strategic technology partners