Executive Director, Head of Biostatistics

Kardigan•Princeton, NJ

2d•Onsite

About The Position

Kardigan is a heart health company focused on preventing and curing cardiovascular disease. The Executive Director, Head of Biostatistics will be the principal statistical authority, leading regulatory strategy, late-stage development decision-making, and the growth of the Biostatistics organization. This role is scientific and strategic, requiring influence with clinical, medical, regulatory, and executive leadership. The ideal candidate has experience in full late-phase development, including NDA filing and FDA interaction, with expertise in precision medicine, regulatory gravitas, and cross-functional leadership.

Requirements

Ph.D. in Biostatistics, Statistics, or a closely related quantitative discipline.
15+ years of experience in pharmaceutical or biotechnology drug development, with substantial late-phase program experience.
Demonstrated experience as the statistical lead or signatory on at least one NDA or BLA submission; must have been in the room, not only in a supporting role.
Direct FDA interaction experience, including Type B or C meetings, statistical briefing documents, and responses to regulatory queries.
Deep expertise in late-phase statistical methodology, including estimand frameworks, adaptive designs, surrogate endpoint validation, precision medicine and responder subgroup analysis, and multiplicity control.
Bayesian methodology proficiency, including prior elicitation, posterior decision frameworks, and simulation-based design evaluation.
Demonstrated ability to influence cross-functional leadership and program decisions through scientific expertise, credibility, and clarity of judgment.
Proven track record of developing and elevating statistical talent in a team environment.
Excellent verbal and written communication skills, with the ability to translate complex statistical concepts for technical, clinical, medical, regulatory, and executive audiences.
Experience working in an environment where knowledge of and adherence to SOPs and regulatory guidelines are required.

Nice To Haves

Cardiovascular or cardiometabolic clinical development experience.
Experience with precision medicine frameworks, biomarker-driven trial design, and responder subgroup methodology in a regulatory submission context.
Strong epidemiology or real-world data fluency, including observational study methodology and defining or refining target patient populations for precision-medicine-driven trials.
Familiarity with digital health endpoints and novel data sources, including wearables or continuous monitoring approaches.
External scientific presence through publications, conference presentations, professional society involvement, or KOL relationships in the cardiovascular or biostatistics community.
Prior experience working in a small, fast-paced, high-growth biotechnology company.

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.
Provide expert leadership in innovative statistical methodology, including precision medicine approaches, responder analyses, adaptive designs, Bayesian methods, and emerging analytical strategies that support Kardigan’s development model.
Serve as a trusted scientific and strategic partner to Clinical Development, Medical, Regulatory Affairs, and executive leadership, providing data-driven guidance on program strategy, statistical risk, trial feasibility, and critical portfolio decisions.
Build, lead, and develop a high-performing Biostatistics organization, mentoring future leaders and establishing a culture of scientific excellence, accountability, innovation, and influence.
Establish statistical standards, governance, quality systems, and submission-ready processes that ensure regulatory compliance, inspection readiness, and consistent analytical excellence across the portfolio.
Oversee external statistical partners and CROs while maintaining scientific ownership, strategic oversight, and accountability for the quality and integrity of all statistical deliverables.
Partner across the Biometrics organization and broader enterprise to strengthen evidence generation, support business development and due diligence activities, and help scale the function as Kardigan continues its growth trajectory.