Director, Biostatistics

Kardigan; South San Francisco (CA); On-site; USD 204,000 - 280,000; Full time

Job summary

An innovative heart health company is seeking a Director of Biostatistics to lead the biometrics function in late-phase cardiovascular drug development. This pivotal role involves overseeing clinical development planning, study design, and statistical analysis while collaborating with cross-functional teams to ensure high-quality outcomes. The ideal candidate will possess a PhD in Statistics or Biostatistics, with a strong background in regulatory standards and statistical methodologies. Join a passionate team dedicated to making cardiovascular disease preventable and curable, and help drive significant advancements in patient care.

Qualifications

• PhD or MS in Statistics/Biostatistics with extensive experience in clinical trials.
• Expertise in statistical methodologies and regulatory standards.

Responsibilities

• Lead biometrics in global project teams for clinical development.
• Collaborate with teams to ensure cohesive project strategies.

Skills

Statistical Methodologies

Regulatory Standards

Communication Skills

SAS

R

Python

CRO Management

Cardiovascular Drug Development

Education

PhD in Statistics or Biostatistics

MS in related field

Tools

SAS

R

Python

Job description

Join to apply for the Director, Biostatistics role at Kardigan.

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. Our mission is to develop multiple targeted treatments in parallel to bring people with cardiovascular diseases to the cures they deserve.

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 patients' lives and prioritizing their needs. We believe in being authentic—leading with truth to create an environment of acceptance. With an eagerness to learn, we foster curiosity and openness to change. We are committed to winning as a team with urgency, excellence, and support for each other. Lastly, we aim to enable the impossible, taking risks to unlock innovation and advance scientific discoveries. These values empower us to make a real difference every day.

Position Details

• Title: Director, Biostatistics
• Department: Development - Data Science
• Reports To: Sr Director, Biostatistics

Job Overview

We seek a highly skilled Biostatistician to lead our biometrics function in late-phase cardiovascular drug development. You will serve as the compound lead, representing biometrics at the project team level, and be responsible for clinical development planning, study design, endpoint selection, statistical analysis, and regulatory strategy. The role involves overseeing CROs and collaborating with cross-functional teams to ensure high-quality analysis and results interpretation. Initially, this is an individual contributor role with potential to grow to include direct reports.

Essential Duties and Responsibilities

1. Lead biometrics in global project teams, contributing to clinical development plans, study designs, endpoints, statistical analysis plans, regulatory submissions, and publications.
2. Collaborate with clinical, regulatory, and medical teams to ensure cohesive project strategies.
3. Develop and review clinical protocols, study reports, and statistical analysis plans.
4. Review CRF designs and specify randomization schedules.
5. Provide statistical input to DMC charters.
6. Oversee CROs or internal teams to deliver analysis outputs and interpret results.
7. Review analysis datasets and perform QC/QA of statistical deliverables.
8. Support regulatory submissions and address questions from agencies.
9. Assist in preparing publications and contribute to process improvements within biostatistics.
10. Ensure compliance with regulatory standards and best practices.

Qualifications and Skills

• PhD in Statistics, Biostatistics, or related field with 8+ years of experience, or MS with 10+ years in clinical trials or healthcare.
• Expertise in statistical methodologies and regulatory standards.
• Excellent communication skills for conveying complex concepts.
• Proficiency in SAS, R, or Python, with experience in advanced analytics.
• Experience managing CROs and cross-functional collaboration.
• Experience with NDAs, MAA’s, and cardiovascular drug development is preferred.
• Ability to work independently and in a team in a fast-paced environment.

Compensation and Additional Details

Exact salary varies based on experience and location. Pay range: $204,000 - $280,000 USD.

Additional Information

• Seniority Level: Director
• Employment Type: Full-time
• Job Function: Research, Analysis, IT