Global Head, Statistical Programming
About The Position
The Global Head of Statistical Programming will provide strategic, operational, and technical leadership for all statistical programming activities across global clinical development programs. This role is accountable for the delivery of high-quality, regulatory-compliant statistical programming outputs across all therapeutic areas, ensuring alignment with global regulatory requirements and organizational objectives. The incumbent will lead and develop a global team, drive innovation in programming standards and technologies. The work location can be in Redmond, WA, Princeton, NJ or Sugarland, TX. Requires fluency in English and Chinese (Mandarin).
Requirements
- MS or PhD in Statistics, Computer Science, Mathematics, or related quantitative discipline
- 15+ years of experience in statistical programming or biostatistics within the pharmaceutical/biotechnology industry
- Proven leadership experience (8+ years) managing global teams and leaders
- Extensive experience supporting multiple global NDA/BLA/MAA submissions
- Demonstrated success in building and scaling global programming organizations
- Deep knowledge of CDISC standards (SDTM, ADaM)
- Strong understanding of global regulatory requirements (FDA, EMA, NMPA, PMDA, etc.)
- Advanced proficiency in SAS and/or R; familiarity with emerging technologies and automation tools
- Strong understanding of end-to-end drug development processes
- Strategic thinker with strong execution capabilities
- Strong stakeholder management and influencing skills at executive level
- Proven ability to drive change and innovation in a global environment
- Fluency in English and Chinese
- Experience working in a global, matrixed organization
Responsibilities
- Define and execute the global statistical programming strategy, including standards, processes, and innovation (e.g., CDISC, automation, AI/advanced analytics), aligned with corporate and clinical development goals
- Provide end-to-end leadership and oversight of statistical programming activities across global clinical trials and regulatory submissions, ensuring timely, high-quality delivery of datasets and TLGs
- Ensure compliance with global regulatory requirements (FDA, EMA, NMPA, PMDA) and CDISC standards (SDTM, ADaM), maintaining continuous inspection readiness
- Lead organizational design, workforce planning, and development of a high-performing global statistical programming team, including talent development, succession planning, and performance management
- Drive operational excellence by overseeing portfolio planning, resource allocation, budgets, timelines, and quality control processes
- Champion innovation and digital transformation through adoption of new technologies, development of programming tools, and scalable solutions
- Provide strategic oversight for submission readiness and regulatory interactions related to statistical programming deliverables
- Build strong relationships with internal and external stakeholders to support global program success
Benefits
- SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
Number of Employees
11-50 employees
