Associate Director, Biostatistics

Kardigan is a cardiovascular health organization focused on advancing treatments for heart disease. Led by experienced founders from MyoKardia, the company maintains a cutting-edge discovery and translational research platform with late-stage drug candidates.

Key Responsibilities

• Cross-functional collaboration on clinical development strategies and study designs
• Protocol development and authoring statistical analysis plans for trials
• Oversight of contract research organizations delivering analysis outputs
• Regulatory support for FDA submissions and addressing agency feedback
• Manuscript and publication preparation
• Mentoring junior statisticians
• Process improvement initiatives across biostatistics functions

Required Qualifications

• PhD in Statistics/Biostatistics with 7+ years experience, OR Master's degree with 10+ years in clinical trials, pharmaceutical development, or healthcare sectors

Preferred Skills

• Advanced statistical methodology and regulatory knowledge
• Machine learning expertise for classification and predictive modeling
• Proficiency in SAS, R, or Python with data visualization capabilities
• CRO management and cross-functional team experience
• NDA/MAA submission background
• Cardiovascular drug development or real-world data experience