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Associate Director, Biostatistics

South San Francisco, California, United States, Princeton, New Jersey, United States

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 our mission to develop multiple targeted treatments in parallel that 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 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.  

 

Position Title: Associate Director, Biostatistics

Department: Development- Data Science

Reports To: Sr Director, Biostatistics

 

Job Overview

We are seeking a highly skilled and motivated Biostatistician to lead our biometrics function in one of the late-phase programs for cardiovascular drug development.  As the Biostatistician, you will be the compound lead, representing biometrics at the project team level.  You will be responsible for discussing and shaping the clinical development plan, study design, endpoint selection, statistical analysis plan, and regulatory submission and publication strategy. This role involves overseeing CROs and collaborating with cross-functional teams to deliver high-quality analysis outputs and interpret results. Initially, this position is an individual contributor role with the potential to expand to include direct reports as the team grows. 

Essential Duties and Responsibilities

  • Serve as the compound lead, representing the biometrics function (biostat, programming and CDM) in global project teams and contribute to the clinical development plans, study designs, endpoint selections, statistical analysis plans, regulatory submissions, and publication strategies.  
  • Collaborate with clinical, regulatory, medical affairs, and other teams to ensure cohesive and integrated project strategies.
  • Contribute to clinical protocol development and study reports, including authoring of the Statistics section and reviewing of other sections by applying statistical principles.
  • Author or review statistical analysis plans for clinical trials and for integrated summaries of safety/effectiveness (ISS/ISE), and author or oversee the development of shells for tables, figures and listings.
  • Review case report form (CRF) designs to ensure data collection meet the requirements of statistical analyses.
  • Design and specify randomization schedules; review and approve test randomization lists.
  • Provide statistical input to data monitoring committee (DMC) charters.
  • Oversee the CROs or internal teams to deliver high-quality and timely analysis outputs and interpret the results.
  • Review analysis dataset specifications and perform QC/QA of statistical deliverables, including validation of key analysis results.  
  • Manage statistical activities in support of NDA/MAA or other regulatory submissions.
  • Address statistical questions/comments from FDA and other regulatory agencies.
  • Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
  • Contribute or lead standardization and process improvement efforts for Biostatistics and contributes to cross-functional process improvement efforts.
  • Provide guidance and oversight to ensure compliance with regulatory standards and best practices.

Qualifications and Preferred Skills

  • PhD in Statistics, Biostatistics, or a related scientific field with 8+ years of experience, or MS with 10+ years of experience in clinical trials, drug development, the pharmaceutical industry, or healthcare
  • Expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards. 
  • Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians.
  • Strong knowledge of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods  
  • Experience in managing CROs and collaborating with cross-functional teams.
  • Experience with NDAs, and MAA’s is highly desired.
  • Experience with cardiovascular drug development is preferred.
  • Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment.

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