CSL · 3 days ago
Senior Biostatistician
Greater Boston
Full-time
Hybrid
Senior Level, Lead/Staff
1+ years expCSL is a biotech company focused on innovation in R&D to improve patient outcomes. They are seeking a Senior Biostatistician who will lead statistical contributions to clinical development programs and be accountable for statistical deliverables in clinical trials and regulatory submissions.
BiotechnologyHealth CareHealth DiagnosticsMedical
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
Required
PhD or MS in Biostatistics, Statistics or related field
Experience: PhD or MS with 1-2 years of experience in drug development
Advanced knowledge and training in applications of statistical methodologies in the context of clinical development
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Leadership Team
Jeffrey Ball
Chief Sustainability Officer
Joy Linton
Strategic Advisor
Recent News
Pharma Letter
2026-01-03
2025-10-29
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