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
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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
#J-18808-Ljbffr