Senior Biostatistician X3 jobs in United States
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CSL · 1 day ago

Senior Biostatistician X3

CSL is a global biotherapeutics leader focused on developing innovative therapies for patients. The Senior Biostatistician will lead statistical components of clinical development programs, ensuring the application of appropriate methodologies and accountability for statistical deliverables.

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
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 developmentData analysisCollaboration

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

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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Company data provided by crunchbase