Principal Biostatistician (Remote)

Principal Biostatistician

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

The Principal Biostatistician provides strategic leadership and operational oversight of statistical design, analysis, and reporting across SELUTION DEB clinical programs. This role ensures the scientific integrity of all biostatistical activities, drives the development and application of robust statistical methods, and leads internal and external data management partners to support clinical development and regulatory submissions.

Key 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.

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.