Principal Biostatistician

CSL•King of Prussia, PA

1d•Hybrid

About The Position

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? 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. 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.

Requirements

PhD or MS in Biostatistics, Statistics
7+ years or relevant work experience in the pharmaceutical industry and/or CRO
Experience 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

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 the 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