Senior Director, 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. Senior Director, Biostatistics Level: Senior Director Hiring Manager: Executive Director, Head of Biostatistics Location: Princeton, NJ Classification: Hybrid – On-site 4 days per week (Mon to Thurs) Travel: As needed, up to 15% About the Team Kardigan’s Biometrics organization is the analytical backbone of our development portfolio. Working closely with Clinical Development, Medical, Regulatory Affairs, Clinical Operations, and Data Management, the team shapes how our studies are designed, how evidence is generated, and how results are interpreted and communicated to health authorities. Biostatistics is a scientific partner in program strategy, not a downstream delivery function. We are building a team that pairs methodological depth with practical judgment and a strong sense of ownership. Team members have the opportunity to influence trial design and development decisions early, apply innovative analytical approaches in a regulatory context, and help establish the standards and ways of working that will carry Kardigan through multiple registration-directed programs. Our work helps Kardigan move with urgency while safeguarding scientific and analytical integrity, ultimately supporting our mission to bring potentially transformative treatments to people living with cardiovascular disease. Job Overview Kardigan is seeking a Senior Director, Biostatistics to serve as the lead statistician for one or more of our late- stage cardiovascular development programs. Reporting to the Executive Director, Head of Biostatistics, this individual owns the statistical strategy and analytical deliverables for their assigned programs, from study design through analysis, reporting, and submission support. This is a hands-on scientific leadership role. The Senior Director is expected to bring methodological rigor and sound judgment to program design questions, to represent Biostatistics credibly on cross-functional program teams, and to serve as a statistical contributor in health authority interactions in partnership with the Head of Biostatistics. The role carries people leadership responsibility for the statisticians supporting assigned programs, along with oversight of the CRO and vendor statistical work those programs depend on. The ideal candidate has meaningful late-phase experience — study design through analysis and submission deliverables — and is comfortable operating with a high degree of independence in a small, fast-moving company while escalating and aligning on significant methodological and regulatory positions with the Head of Biostatistics. Main Responsibilities • Serve as the lead statistician for one or more late-stage cardiovascular development programs, owning the statistical strategy and analytical deliverables for those programs under the direction of the Head of Biostatistics. • Contribute to clinical development strategy by informing study design, endpoint selection, estimand frameworks, sample size and power considerations, and evidence-generation plans from protocol concept through submission. • Author, review, and own core statistical documents for assigned programs, including statistical sections of protocols, statistical analysis plans, randomization specifications, and the statistical content of clinical study reports. • Prepare statistical content supporting interactions with the FDA and other health authorities — including briefing package sections, meeting preparation materials, and responses to agency queries — and participate in those interactions alongside the Head of Biostatistics. • Apply late-phase statistical methodology relevant to Kardigan’s programs, including responder and subgroup analyses, adaptive design elements, Bayesian approaches, multiplicity control, and missing data strategies, and recommend approaches that are both scientifically sound and regulatorily credible. • Serve as the statistical partner to Clinical Development, Medical, Regulatory Affairs, Clinical Operations, and Data Management, providing data-driven input on trial feasibility, statistical risk, and program-level decisions. • Manage, mentor, and develop the biostatisticians supporting assigned programs, providing technical review, coaching, and career development. • Oversee statistical work performed by CROs and external partners for assigned programs, maintaining scientific ownership and accountability for the quality, timeliness, and integrity of all deliverables. • Support data monitoring committee activities, interim analyses, and unblinding procedures for assigned programs in accordance with applicable SOPs and regulatory guidelines. • Contribute to the development and adoption of statistical standards, governance, quality systems, and submission-ready processes established across the Biostatistics function, and support inspection readiness. • Provide statistical input to evidence-generation, publication, and business development or due diligence activities as needed. About You Basic Qualifications • Ph.D. in Biostatistics, Statistics, or a closely related quantitative discipline, or a Master’s degree in a comparable discipline with commensurate additional experience. • 10+ years of experience in pharmaceutical or biotechnology drug development with a Ph.D., or 13+ years with a Master’s degree, including substantial late-phase program experience. • Experience contributing to at least one NDA, BLA, or MAA submission, with direct responsibility for statistical deliverables supporting that submission. • Experience preparing statistical content for health authority interactions, including briefing documents and responses to regulatory queries. • Strong working knowledge of late-phase statistical methodology, including estimand frameworks, multiplicity control, missing data approaches, and responder or subgroup analysis. • Working knowledge of Bayesian methods and simulation-based design evaluation. • Demonstrated ability to work effectively across functions and to influence program decisions through scientific expertise, credibility, and clarity of judgment. • Experience mentoring or managing statisticians. • Proficiency in SAS and/or R. • Excellent verbal and written communication skills, with the ability to translate complex statistical concepts for clinical, medical, regulatory, and cross-functional audiences. • Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required. Preferred Qualifications • Cardiovascular or cardiometabolic clinical development experience. • Experience with biomarker-driven trial design and responder subgroup methodology in a regulatory context. • Hands-on experience implementing adaptive or group sequential designs. • Familiarity with real-world data and observational study methodology, including approaches to defining or refining target patient populations. • Working knowledge of CDISC standards (SDTM and ADaM) and submission dataset requirements. • External scientific presence through publications, conference presentations, or professional society involvement. • Prior experience in a small, fast-paced, high-growth biotechnology company.