Senior Director, Biostatistics

Kardigan; Princeton (NJ); Hybrid; USD 257,000 - 335,000; Full time

Job summary

Kardigan is seeking a Senior Director, Biostatistics to lead statistical strategy for late-stage cardiovascular programs and to serve as the statistical voice in health authority interactions.

This hands-on leadership role requires deep expertise in biostatistics, trial design, and regulatory submissions, with on-site presence in Princeton, NJ. You will mentor statisticians and oversee CRO work within a small, fast-moving biotech setting.

Qualifications

• Ph.D. in Biostatistics or related field required, or a master’s with extensive experience.
• 10+ years in pharma/biotech drug development with late-phase experience.
• Experience NDA/BLA/MAA submissions and regulatory interactions.
• Proficiency in SAS and/or R; strong statistical knowledge of estimand, multiplicity, missing data.
• Ability to work on-site four days per week in Princeton, NJ.

Responsibilities

• Lead statistician for late-stage cardiovascular programs; own strategy and deliverables.
• Inform study design, endpoints, estimands, sample size, evidence plans.
• Author and review protocols, SAPs, randomization specs, analysis content.
• Prepare statistical content for FDA interactions; be statistical voice.
• Oversee CRO/vendor statistics; mentorship and team leadership.
• Collaborate across functions and oversee governance and standards.

Skills

Biostatistics

Clinical trial design

Regulatory interactions

Statistical leadership

SAS

R

Education

Ph.D. in Biostatistics or Statistics

Master's in a related quantitative field

Tools

SAS

R

Job description

Sep 24, 2026

$257,000 - $335,000/year

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.

About the Job

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 the statistical voice for their programs’ health authority interactions, aligning with the Head of Biostatistics. Just as important as technical skill is disposition: this person brings options and creative, defensible paths, and works to build Biostatistics’ credibility as a strategic partner rather than a downstream service.

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, from 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.

This is a high-visibility, high-autonomy role, with real regulatory exposure and a clear path toward broader statistical leadership – is well suited to a senior statistician who wants to stay close to the science and tell the story with the data.

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 serve as the statistical voice in those interactions for assigned programs, aligning with 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. Partner with the function modeling and simulation expertise where deeper quantitative evaluation is warranted.

Serve as the statistical partner to Clinical Development, Medical, Regulatory Affairs, Clinical Operations, Data Analytics, 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. Direct-report scope is typically one to two statisticians per program initially, alongside significant CRO oversight, and grows with the portfolio.

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.

Demonstrated solution‑orientation and creative problem‑solving - a track record of finding defensible paths to a business need rather than gatekeeping, and of building credibility for Biostatistics as an early, strategic partner.

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.

Ability to work on-site four days per week in Princeton, New Jersey.

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.

Kardigan is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace and consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, breastfeeding, gender identity, gender expression, and sexual orientation), national origin, age, disability, genetic information, veteran status, marital status, citizenship status, or any other characteristic protected by applicable federal, state, or local law. We are committed to providing reasonable accommodations to qualified individuals with disabilities throughout the application and employment process.

• Prior experience in a small, fast-paced, high-growth biotechnology company.

Exact Compensation may vary based on skills, experience and location.

Pay range

$257,000—$335,000 USD

Cardiovascular disease is the leading cause of death in the world.We are developing novel medicines to change that.

Kardigan is a pioneering heart health company focused on transforming cardiovascular drug development, aiming to provide functional cures rather than mere symptom management.

Biotechnology Research Research Services Professional Services

Company size 51–200 employees

Company type Privately held Founded 2023

Total funding $554M Series B

Team growth

Momentum

50% in 12 mo

152 employees on LinkedIn

Jul 23 Apr 26

Funding history

Series B$254M

Oct 2025

Series A - Sequoia Heritage, Perceptive Advisors, ARCH Venture Partners$300M

Jan 2025