Senior Director, Biostatistics

Senior Director, Biostatistics

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.