Remote Principal Biostatistician - Cardiovascular Trials Lead

Cordis; Irvine (CA); Hybrid; USD 105,000 - 180,000; Full time

Job summary

Cordis, in collaboration with Selution, is seeking a Principal Biostatistician to provide strategic leadership across SELUTION DEB clinical programs. You will guide study design, analysis plans, and regulatory-facing statistics, ensuring integrity and compliance across all trials.

You will supervise vendors, collaborate with Clinical, Regulatory and Data Management teams, and oversee data management and statistical reporting, driving continuous improvement and adherence to GCP, ICH, ISO and FDA

Qualifications

• Master’s degree in Statistics, Biostatistics, or related discipline.
• Minimum 5 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.

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.

Skills

Biostatistics

Clinical trial design

Regulatory submissions

Vendor management

Data management

GCP/ICH compliance

Statistical programming

Education

Master’s degree in Statistics or Biostatistics

Tools

SAS

SPSS

MATLAB

Job description

Cordis, in collaboration with Selution, is seeking a Principal Biostatistician to provide strategic leadership across SELUTION DEB clinical programs. You will guide study design, analysis plans, and regulatory-facing statistics, ensuring integrity and compliance across all trials.

You will supervise vendors, collaborate with Clinical, Regulatory and Data Management teams, and oversee data management and statistical reporting, driving continuous improvement and adherence to GCP, ICH, ISO and FDA