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 design and clinical development plans, including Go-No Go criteria and probability of technical success calculations
Minimum Qualifications and Experience 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
The expected base salary range for this position at hiring is $162,000 - $202,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position for the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.
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