Global Head, Statistical Programming
Behavioral Health Market Context
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Benefits
Compensation and Benefits: The expected base salary range for this position is $200,000 - $300,000 annuallyActual compensation will be based on a variety of factors, including but not limited to a candidate's leveling, qualifications, experience, and skillsSystImmune 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
Qualifications
- •Requires fluency in English and Chinese (Mandarin)
- •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
- •12 more items(s)
Responsibilities
- •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
- •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
- •8 more items(s)
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