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
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
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