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. 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?

Position Purpose

You will lead components of statistical contribution to a clinical development program. The Principal Biostatistician will implement statistical strategies for clinical trials and regulatory submissions within the program, and is accountable for the statistical deliverables.

Work Environment
- This is a hybrid position based in King of Prussia, PA or Waltham, MA with a minimum of 3 days onsite in the designated work location weekly. Relocation and mobility assistance are not provided.

Main Responsibilities




- 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 des

📌 Principal Biostatistician (Río Negro)
🏢 CSL
📍 Río Negro