Senior Statistician

Role Summary

Senior Biostatistician responsible for all statistical aspects of clinical trials, leading statistical input from trial design to analysis, and overseeing CRO deliverables to ensure high-quality statistical outputs in support of clinical development programs.

Responsibilities

• Serve as the lead statistician for at least one study within clinical development programs, providing strategic statistical input from trial design to analysis.
• Collaborate with cross-functional teams on study design, including sample size, randomization procedures, endpoint selection, and case report form design.
• Develop, oversee, and ensure alignment of Statistical Analysis Plans (SAPs) with study objectives and regulatory compliance.
• Oversee CRO deliverables, ensuring accuracy, quality, and integrity of statistical outputs, including tables, listings, and figures.
• Foster collaborative relationships within the clinical department and with external vendors to maintain effective communication and project integrity.
• Provide comprehensive statistical support across all phases of clinical trial and project development, including the design of clinical study reports.

Qualifications

• A Master‚Äôs degree in statistics or a related field, with at least 5 years of relevant experience in clinical trial analysis.
• Demonstrated expertise in statistical analysis within clinical or related subjects; oncology experience is a plus.
• Familiarity with international standards (ICH, GCP, CDISC) and clinical study regulations.
• Proficiency in statistical software packages (e.g., SAS, R).
• Excellent communication and interpersonal skills, with the ability to translate complex statistical concepts for non-technical audiences.
• Strong leadership and collaboration skills, able to work on multiple projects simultaneously and under pressure.

Skills

• Statistical principles applied to clinical research
• Regulatory environment knowledge
• Cross-functional collaboration
• CRO oversight
• Statistical software proficiency (SAS, R)

Education

• Master‚Äôs degree in statistics or related field (required).