Global Head, Statistical Programming

<span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;">SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.<br>&#160;<br><span style="line-height:115%;">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.</span><br><br><span style="line-height:115%;">The incumbent will lead and develop a global team, drive innovation in programming standards and technologies.<br><br>The work location can be in Redmond, WA, Princeton, NJ or Sugarland, TX. Requires fluency in English and Chinese (Mandarin).</span><br><br><strong>Key Responsibilities</strong></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">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</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">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</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Ensure compliance with global regulatory requirements (FDA, EMA, NMPA, PMDA) and CDISC standards (SDTM, ADaM), maintaining continuous inspection readiness</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Lead organizational design, workforce planning, and development of a high-performing global statistical programming team, including talent development, succession planning, and performance management</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Drive operational excellence by overseeing portfolio planning, resource allocation, budgets, timelines, and quality control processes</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Champion innovation and digital transformation through adoption of new technologies, development of programming tools, and scalable solutions</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Provide strategic oversight for submission readiness and regulatory interactions related to statistical programming deliverables</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Build strong relationships with internal and external stakeholders to support global program success</span></span></span></li></ul><div style="margin-bottom:11px;"><br><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;"><strong>Qualifications&#160;</strong></span></span></span><ul style="margin-bottom:11px;"><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">MS or PhD in Statistics, Computer Science, Mathematics, or related quantitative discipline</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">15+ years of experience in statistical programming or biostatistics within the pharmaceutical/biotechnology industry</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Proven leadership experience (8+ years) managing global teams and leaders</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Extensive experience supporting multiple global NDA/BLA/MAA submissions</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Demonstrated success in building and scaling global programming organizations</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Deep knowledge of CDISC standards (SDTM, ADaM)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Strong understanding of global regulatory requirements (FDA, EMA, NMPA, PMDA, etc.)</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Advanced proficiency in SAS and/or R; familiarity with emerging technologies and automation tools</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Strong understanding of end-to-end drug development processes</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Strategic thinker with strong execution capabilities</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Strong stakeholder management and influencing skills at executive level</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Proven ability to drive change and innovation in a global environment</span></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><strong><span style="line-height:115%;">Fluency in English and Chinese</span></strong></span></span></li><li style="margin-bottom:11px;"><span style="font-size:14px;"><span style="font-family:Arial, Helvetica, sans-serif;"><span style="line-height:115%;">Experience working in a global, matrixed organization</span></span></span></li></ul>