Skip to main content
Posted 23 July, 2026

Principal Biostatistician

CSL
King of Prussia, PA, US Full Time

Job Description

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.

\n

\n

Could you be our next Principal Biostatistician? The role is based in our King of Prussia, PA or Waltham, MA locations. This is a hybrid position and is onsite a minimum of 3 days per week.

\n

\n

Position Purpose:

\n

\n

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

\n

\n

Main Responsibilities:

\n
    \n
  • \n

    Input to statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions

    • \n
  • \n

    Lead components and fully support Biostatistics conduct in study design, protocol development, data collection, data analysis, reporting, and submission preparation

    • \n
  • \n

    Author the initial statistical analysis plan for clinical trials and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan.

    • \n
  • \n

    Support Biostatistics interactions with regulatory authorities (eg FDA, EMA, PMDA)

    • \n
  • \n

    Be responsible for interpreting analysis results and ensuring reporting accuracy

    • \n
  • \n

    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.

    • \n
  • \n

    Be accountable for the TFL/CDISC package for study report and regulatory submission

    • \n
  • \n

    Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations

    • \n
\n

\n

Minimum Qualifications and Experience Requirements:

\n
    \n
  • \n

    PhD or MS in Biostatistics, Statistics

    • \n
  • \n

    7+ years or relevant work experience in the pharmaceutical industry and/or CRO

    • \n
  • \n

    Experience either managing a CRO, or having worked in a CRO

    • \n
  • \n

    Experience providing statistical leadership at a study level

    • \n
  • \n

    Demonstrated statistical contribution in facilitating and optimizing clinical development

    • \n