Executive Director, Head of Biostatistics

About Us Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020. We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients. At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families , we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic —leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn , we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries. These values are the foundation of our work, empowering us to make a real difference, every day. Department: Biometrics Reports To: VP, Biometrics Location On-site: Princeton, NJ or South San Francisco, CA — 4 days per week Direct Reports: Biostatistics Program Leads Role Mandate: The Executive Director, Head of Biostatistics will serve as Kardigan’s principal statistical authority, leading regulatory strategy, late-stage development decision-making, and the continued growth of a highly influential Biostatistics organization supporting multiple registration-directed cardiovascular programs. Position Summary: The Executive Director, Head of Biostatistics is the scientific, strategic, and operational leader of Kardigan’s Biostatistics function. Reporting to the VP, Biometrics, this individual serves as the principal statistical authority across the organization — shaping program strategy, owning regulatory interactions, and driving analytical excellence from late-phase development through NDA submission and beyond. This is a scientific leadership role, not a coordination function. The incumbent must command credibility with clinical, medical, regulatory, and executive leadership; bring bold, regulatorily credible ideas to program design and analytical strategy; and hold the Biostatistics function to a standard of proactivity and influence that directly shapes program outcomes. The ideal candidate has been through the full arc of late-phase development — from study design through NDA filing and FDA interaction — and brings the precision medicine methodology depth, regulatory gravitas, and cross-functional leadership capability that Kardigan’s pipeline demands. Essential Duties and Responsibilities · Serve as Kardigan’s senior statistical leader and principal authority on biostatistical strategy across a portfolio of late-stage cardiovascular development programs advancing toward regulatory submission. · Shape clinical development strategy by influencing study design, endpoint selection, estimand frameworks, evidence-generation plans, and key development decisions from protocol concept through NDA submission. · Lead regulatory statistical strategy and serve as the primary statistical representative in interactions with FDA and other health authorities, including briefing packages, regulatory meetings, submission support, and responses to agency inquiries. · P…