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.
It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co‑founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting‑edge discovery and translational research platform, a pipeline of late‑stage candidates, and an industry‑leading team that is driven to improve the lives of patients.
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.
Department:
Development - Data Science
Reports To:
Senior Director, Biostatistics
Location:
Princeton, NJ or South San Francisco, CA – On‑site 4 days per week (Mon to Thurs)
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 to support the pursuit of precision medicine. This role involves overseeing CROs and collaborating with cross‑functional teams to deliver high‑quality analysis outputs and interpret results.
This position reports to the Senior Director, Biostatistics based in South San Francisco, CA. The role has one opening and may be located in either our Princeton, NJ office or our South San Francisco, CA office.
Essential Duties and 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 the Statistics section and reviewing other sections by applying statistical principles.
Author or review statistical analysis plans for clinical trials and 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 meets 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 contribute to cross‑functional process improvement efforts.
Provide guidance and oversight to ensure compliance with regulatory standards and best practices.
Qualifications and Preferred Skills
Ph.D. in Statistics, Biostatistics, or a related scientific field with 8+ years of experience, or M.S. 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 and 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 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.
Experience with NDAs, and MAA’s is highly desired.
Experience with cardiovascular drug development and digital health data or real‑world data is preferred.
Demonstrated ability to work independently and as part of a team in a fast‑paced, dynamic environment.
Compensation and Benefits Pay range: $204,000 - $280,000 USD
Equal Employment Opportunity Kardigan is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law. We are committed to providing a diverse and inclusive workplace and encourage applications from all qualified candidates.
Disability and Veterans We welcome qualified individuals with disabilities and veterans to apply. If you have a disability that may require accommodation, please let us know. Katäburg complies with the federal and state laws that provide accommodation and assistance for qualified individuals with disabilities. Veterans are encouraged to apply and are protected from discrimination in accordance with the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA).
#J-18808-Ljbffr
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 Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.
Led by Tassos Giannakakos, Jay Edelberg, M.D. and Bob McDowell, Ph.D., Kardigan’s co‑founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.
We have a cutting‑edge discovery and translational research platform, a pipeline of late‑stage candidates, and an industry‑leading team that is driven to improve the lives of patients.
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.
Department:
Development - Data Science
Reports To:
Senior Director, Biostatistics
Location:
Princeton, NJ or South San Francisco, CA – On‑site 4 days per week (Mon to Thurs)
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 to support the pursuit of precision medicine. This role involves overseeing CROs and collaborating with cross‑functional teams to deliver high‑quality analysis outputs and interpret results.
This position reports to the Senior Director, Biostatistics based in South San Francisco, CA. The role has one opening and may be located in either our Princeton, NJ office or our South San Francisco, CA office.
Essential Duties and 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 the Statistics section and reviewing other sections by applying statistical principles.
Author or review statistical analysis plans for clinical trials and 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 meets 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 contribute to cross‑functional process improvement efforts.
Provide guidance and oversight to ensure compliance with regulatory standards and best practices.
Qualifications and Preferred Skills
Ph.D. in Statistics, Biostatistics, or a related scientific field with 8+ years of experience, or M.S. 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 and 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 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.
Experience with NDAs, and MAA’s is highly desired.
Experience with cardiovascular drug development and digital health data or real‑world data is preferred.
Demonstrated ability to work independently and as part of a team in a fast‑paced, dynamic environment.
Compensation and Benefits Pay range: $204,000 - $280,000 USD
Equal Employment Opportunity Kardigan is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law. We are committed to providing a diverse and inclusive workplace and encourage applications from all qualified candidates.
Disability and Veterans We welcome qualified individuals with disabilities and veterans to apply. If you have a disability that may require accommodation, please let us know. Katäburg complies with the federal and state laws that provide accommodation and assistance for qualified individuals with disabilities. Veterans are encouraged to apply and are protected from discrimination in accordance with the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA).
#J-18808-Ljbffr