Principal Biostatistician X3 jobs in United States
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CSL · 2 months ago

Principal Biostatistician X3

positionKing of Prussia, PA
timeFull-time
remoteHybrid
senioritySenior Level, Lead/Staff
date7+ years exp

CSL is a global biotherapeutics leader focused on delivering innovative therapies for patients. The Principal Biostatistician will lead statistical contributions to clinical development programs, ensuring the application of appropriate methodologies and managing deliverables for regulatory submissions.

BiotechnologyHealth CareHealth DiagnosticsMedical
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Comp. & Benefits

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

Qualification

PhD in BiostatisticsStatistical leadershipClinical trial designCROsStatistical analysis planData analysisRegulatory submissionsCollaboration skills

Required

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

Company

CSL

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CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
dateFounded in 1916
location
Melbourne, Victoria, AUS
people-size10001+ employees
web-link
https://www.csl.com

Funding

Current Stage
Public Company
Total Funding
$111M
2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO

Leadership Team

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Jeffrey Ball
Chief Sustainability Officer
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Joy Linton
Strategic Advisor
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Recent News

Pharma Letter
MHRA approves Kostaive mRNA COVID-19 vaccine
2026-01-03
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Data Published in the New England Journal of Medicine Confirm the Long-term Durability and Safety of HEMGENIX® (etranacogene dezaparvovec-drlb) Over Five Years
2025-12-07
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CSL just upgraded at Canaccord, here's why
2025-10-29
Company data provided by crunchbase