Global Head, Statistical Programming

Salary :

$200,000 - 300,000 yearly

Company : Systimmune

Job Type : Full Time

Princeton, Nj

Number of Applicants

000+

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Job Description - Global Head, Statistical Programming

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.

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).

Key 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

Qualifications

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

Compensation and Benefits:
The expected base salary range for this position is $200,000 - $300,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s leveling, qualifications, experience, and skills.

While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. 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.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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Global Head, Statistical Programming

Job Description - Global Head, Statistical Programming

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