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Kardigan · 4 days ago

Associate Director, Biostatistics

Princeton, NJ

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$174K/yr - $244K/yr

7+ years exp

Kardigan is a heart health company focused on making cardiovascular disease preventable and curable. They are seeking an Associate Director of Biostatistics to lead the biometrics function for late-phase cardiovascular drug development, collaborating with cross-functional teams and overseeing statistical analysis plans and regulatory submissions.

Artificial Intelligence (AI)BiopharmaHealth CareMedical

H1B Sponsor Likely

Responsibilities

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

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

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

Mentor junior statisticians

Qualification

PhD in StatisticsStatistical software SASStatistical software RStatistical software PythonClinical trials experienceMachine learning knowledgeCardiovascular drug developmentMentoring junior statisticiansCommunication skillsTeam collaboration

Required

PhD in Statistics, Biostatistics, or a related scientific field with 7+ 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

Knowledgeable of machine learning approaches for classification and predictive modeling

Excellent communication and presentation skills, with the ability to convey complex statistical concepts to non-statisticians

Strong knowledge and hands-on experience of statistical software (SAS, R or Python) and proficiency in implementation of advanced analytical methods especially for data visualization

Experience in managing CROs and collaborating with cross-functional teams

Demonstrated ability to work independently and as part of a team in a fast-paced, dynamic environment

Preferred

Experience with NDAs, and MAA's is highly desired

Experience with cardiovascular drug development and digital health data or real-world data is preferred

Company

Kardigan

Kardigan develops personalized medicines using AI and data to target and treat the root causes of cardiovascular diseases.

Founded in 2023

South San Francisco, California, USA

51-200 employees

https://www.kardigan.bio

H1B Sponsorship

Kardigan has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (1)