Kardigan is working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world by developing multiple targeted treatments in parallel.
Requirements
- 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.
- Knowledgeable of machine learning approaches for classification and predictive modeling.
- 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.
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.
Other
- Mentor junior statisticians.
- 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.
- Support and contribute to the preparation of publications, including manuscripts, posters and oral presentations.
- Address statistical questions/comments from FDA and other regulatory agencies.
