Lead a global Statistical Programming organisation supporting all phases of Clinical Development. Provide global leadership, mentoring, and line management for permanent and contract statistical programmers. Drive automation and AI adoption in partnership with enterprise R&D technology teams.
Key Highlights
Key Responsibilities
Technical Skills Required
Benefits & Perks
Job Description
Senior Director, Global Head of Clinical Statistical Programming
Location: United States (Remote)
Eligibility: US-based candidates only
Employment Type: Full-time
Compensation: USD 252,000 – 378,000 base + bonus & long-term incentives
About the Role
We are seeking an accomplished Senior Director, Head of Clinical Statistical Programming to lead a global Statistical Programming organisation supporting all phases of Clinical Development.
Reporting to executive leadership within Data Science and Medical Affairs, this role holds end-to-end accountability for statistical programming strategy, delivery, regulatory submissions, and innovation. You will lead global teams, oversee CRO/FSP partnerships, ensure regulatory-grade quality, and drive automation and AI-enabled transformation across the statistical programming lifecycle.
This is a high-impact leadership role for a senior programming executive with deep regulatory expertise and a passion for modernising clinical data delivery.
Key Responsibilities
- Provide global leadership, mentoring, and line management for permanent and contract statistical programmers
- Own statistical programming strategy across all clinical development studies
- Lead programming activities for global regulatory submissions (NDA/BLA/MAA)
- Ensure delivery of high-quality datasets, tables, listings, and figures (TLFs)
- Establish and maintain programming standards, SOPs, validation practices, and documentation
- Ensure inspection readiness and audit-compliant filing of study documentation
- Oversee vendor qualification, governance, and performance management (CRO/FSP models)
- Forecast and manage global programming resources to meet portfolio demands
- Drive automation and AI adoption in partnership with enterprise R&D technology teams
- Represent Clinical Statistical Programming in cross-functional governance and external forums
- Stay current with advances in SAS, R, Python, and emerging analytics technologies
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Required Experience & Capabilities
- 10+ years of statistical programming experience in Pharma, Biotech, or CRO environments
- 7+ years in senior people leadership roles
- Proven leadership of global regulatory submissions (FDA, EMA, PMDA, and others)
- Strong expertise in CDISC standards, electronic submissions, and clinical reporting
- Extensive experience managing CROs and flexible resourcing models
- Advanced SAS expertise; working knowledge of R and Python strongly preferred
- Strong understanding of global clinical trial design, analysis, and reporting requirements
- Demonstrated strategic leadership, decision-making, and stakeholder influence
- Ability to lead in fast-paced, high-complexity development environments
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Education
- Bachelor’s degree in Statistics, Mathematics, or a related discipline (required)
- Master’s degree or higher strongly preferred
Why This Role
- Executive-level ownership of global clinical programming strategy
- Direct influence on regulatory success and development acceleration
- Opportunity to lead AI-driven transformation in statistical programming
- Fully remote role with global scope
- Competitive executive compensation with bonus and equity participation
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