Principal Biostatistician (Remote)

Cordis•Irvine, CA

8d•Remote

About The Position

Selution, in partnership with Cordis, develops and commercializes drug-device combination products for coronary and peripheral artery disease. The Principal Biostatistician provides strategic leadership and operational oversight of statistical design, analysis, and reporting across SELUTION DEB clinical programs. The role safeguards the scientific integrity of biostatistical activities, develops and applies robust statistical methods, and leads internal and external data management partners in support of clinical development and regulatory submissions.

Requirements

Master’s degree in Statistics, Biostatistics, or a related discipline.
At least 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.
At least 2 years of experience in cardiovascular trials.
In-depth knowledge of statistical programming, such as SAS, SPSS, or MATLAB.
Demonstrated experience overseeing external vendors and statistical teams.

Responsibilities

Serve as statistical lead across SELUTION DEB clinical studies and manage 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 to promote 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 support high-quality, timely delivery of data deliverables.
Oversee database management, programming, and statistical reporting activities.
Improve statistical standards, operating procedures, and data-sharing processes.
Ensure 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.