Senior Principal Biostatistician jobs in United States
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Cordis · 2 days ago

Senior Principal Biostatistician

positionIrvine, CA
timeFull-time
remoteHybrid
senioritySenior Level, Lead/Staff
money$140K/yr - $200K/yr
date10+ years exp

Cordis is a company specializing in the development of advanced drug device combination products for the treatment of coronary and peripheral artery disease. The Senior Principal Biostatistician provides strategic leadership and operational oversight of statistical design, analysis, and reporting across clinical programs, ensuring scientific integrity and compliance with regulatory requirements.

Health CareHealth DiagnosticsMedical
badNo H1BnoteU.S. Citizen Onlynote

Responsibilities

Serve as the statistical lead across SELUTION DEB clinical studies, managing all internal and outsourced biostatistical and programming activities
Provide strategic input into study design, clinical development planning, and regulatory submissions
Author statistical sections of clinical trial protocols and develop Statistical Analysis Plans (SAPs)
Oversee statistical analysis, interpretation, and presentation of clinical trial data for publications and regulatory filings
Ensure data integrity, compliance, and readiness for regulatory review and inspections
Lead data analysis strategy, ensuring standardization, efficiency, and reproducibility across programs
Collaborate with Clinical, Regulatory, and Data Management teams to align statistical methodologies with project goals
Supervise external vendors and CROs to ensure high-quality and timely delivery of data deliverables
Oversee database management, programming, and statistical reporting activities
Drive continuous improvement of statistical standards, operating procedures, and data-sharing processes
Ensure all statistical activities comply with GCP, ICH, ISO, FDA, and other regulatory requirements
Promote data integrity, transparency, and excellence in quantitative analysis to support evidence generation and decision-making

Qualification

BiostatisticsClinical trial data managementStatistical programmingCardiovascular trialsEDC systemsVendor managementMentoring

Required

Master's degree in Statistics, Biostatistics, or related discipline
Minimum 10 years of experience in the pharmaceutical, biotechnology, or medical device industry
Expertise in clinical trial data management and biostatistical processes for IDE/PMA submissions
Minimum 2 years of experience in cardiovascular trials
In-depth knowledge of statistical programming (e.g., SAS, SPSS, MATLAB)
Demonstrated experience overseeing external vendors and statistical teams

Preferred

Prior experience managing or mentoring biostatistics personnel
Doctorate in Biostatistics or related field
Working knowledge of EDC systems and data governance frameworks

Company

Cordis

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Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
dateFounded in 1959
location
Hialeah, Florida, USA
people-size1001-5000 employees
web-link
https://www.cordis.com/

Funding

Current Stage
Late Stage
Total Funding
unknown
2021-03-12Acquired

Leadership Team

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Scott Drake
Chief Executive Officer
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Recent News

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Company data provided by crunchbase