Principal Biostatistician

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CSL 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. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Principal Biostatistician? The job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report 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. Be accountable for timely completion and quality of the statistical analysis plan.
• Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA).
• Be responsible for interpreting analysis results and ensuring reporting accuracy.
• Manage outsourcing operations or work with internal statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP.
• Conduct reviews of deliverables to ensure quality.
• Be 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 or 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.

• Statistical analysis and methodologies.
• Clinical trial design and execution.
• Regulatory submission processes.

• Associate

• Full‑time

• Research

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