Executive Director, Head of Biostatistics
Kardigan · Princeton, New Jersey, United States, South San Francisco, California, United States
Posted about 3 months ago
or apply directly on Kardigan's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 82 days Kardigan's roles stay open a median of 83 days
- Reposted
- No
- Salary listed
- No 0% of Kardigan's roles list one
- Ghost-job risk at Kardigan
- high 38 stale, 4 reposted of 38 open
- Hiring momentum
- 54 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-10-25
Measured from postings appearing on and disappearing from Kardigan's own greenhouse board since 2026-08-03. Full hiring picture for Kardigan.
About this role
The Executive Director, Head of Biostatistics at Kardigan will lead the biostatistics function, shaping clinical development strategies and regulatory interactions for late-stage cardiovascular programs. This role involves overseeing statistical methodologies, mentoring a high-performing team, and ensuring compliance with regulatory standards. The position requires significant experience in drug development and direct engagement with regulatory bodies, particularly the FDA.
- benefits
- 1/5
- freshness
- 1/5
- career value
- 5/5
- role clarity
- 5/5
- pay transparency
- 0/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Kardigan as an employer.
What you need
- 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
- 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
Nice to have
- 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
Worth weighing
- No specific benefits listed in the posting
- Exact compensation may vary based on skills, experience, and location, but a pay range is provided ($250,000 — $350,000 USD)
- Role emphasizes leadership and strategic influence rather than coordination, which may appeal to candidates looking for a high-impact position
Summarised from Kardigan's posting. Read the full original.
Listed by Kardigan on their greenhouse job board, last confirmed open on 2026-10-25. PitchMeAI is not the employer.
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