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CSL · 6 days ago

Senior Biostatistician

Greater Philadelphia

Full-time

Hybrid

Senior Level, Lead/Staff

1+ years exp

CSL is a biotech company focused on delivering impactful therapies for patients. They are seeking a Senior Biostatistician to provide and lead statistical components for clinical development programs, ensuring the implementation of statistical strategies and accountability for deliverables.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Hiring Manager

Jamie O'Malley

Responsibilities

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

Provide statistical support in data collection, data analysis, reporting, and submission preparation

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

Support improvement initiatives and related standards for infrastructure / process / scientific consulting

Qualification

BiostatisticsStatistical methodologiesClinical developmentDrug development experienceStatistical analysisData analysisReporting accuracy

Required

PhD or MS in Biostatistics, Statistics or related field

Experience: PhD or MS with 1-2 years of experience in drug development

Competencies: Advanced knowledge and training in applications of statistical methodologies in the context of clinical development

Company

CSL

Glassdoor4.6

CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.

Founded in 1916

Melbourne, Victoria, AUS

10001+ employees

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

Jeffrey Ball

Chief Sustainability Officer

Joy Linton

Strategic Advisor

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

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CSL just upgraded at Canaccord, here's why

2025-10-29

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