Principal Biostatistician X3

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CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project‑led structure and a focus on collaboration, we’re building a future‑ready team that thrives in dynamic biotech ecosystems. The Principal Biostatistician position is based in the King of Prussia, PA, Waltham MA, and Maidenhead UK offices. This is a hybrid role, onsite three days a week, reporting to the Director of Biostats.

• Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
• Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation.
• Author the initial statistical analysis plan for clinical trials and regulatory submissions, ensuring timely completion and quality.
• Support Biostatistics interactions with regulatory authorities (e.g., FDA, EMA, PMDA).
• Interpret analysis results and ensure reporting accuracy.
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects, ensuring timeliness and quality of deliverables by CRO/FSP and conduct reviews to ensure quality.
• Accountable for the TFL/CDISC package for study report and regulatory submission.
• Provide statistical thought partnership for innovative study design and clinical development plans, including Go‑No Go criteria and probability of technical success calculations.

• PhD or MS in Biostatistics, Statistics.
• 7+ years of relevant work experience.
• Experience with CROs (either managing a CRO or having worked in a CRO).
• Experience providing statistical leadership at a study level.
• Demonstrated statistical contribution in facilitating and optimizing clinical development.

CSL employees working at least 30 hours per week are eligible for benefits effective day one. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits—including health care, financial protection, mental health resources, and charitable matching contributions—to support employees at every life stage. Please review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global biotherapeutics leader driven by the promise to save lives. Focused on serving patients’ needs with the latest technologies, we discover, develop, and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapeutic areas. We use a strategic scientific platform of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continual innovation and refine ways our products address unmet medical needs.

At CSL, Inclusion and Belonging is at the core of our mission. By celebrating our differences and creating a culture of curiosity and empathy, we better understand and connect with our patients and donors, foster strong relationships with stakeholders, and sustain a diverse workforce that moves our company and industry into the future.