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HeartFlow is a publicly traded medical technology company (HTFL) pioneering AI-driven solutions for coronary artery disease diagnosis and management. The company's flagship product, HeartFlow FFR_CT Analysis, uses cutting-edge AI to create 3D models of coronary arteries and assess blood flow impact. The product is cleared in the US, UK, Europe, Japan, and Canada, and has been used for over 500,000 patients worldwide.
The Associate Clinical SAS Programmer/Junior Statistician will play a pivotal role in the clinical trial lifecycle, transforming raw clinical trial data into analysis-ready datasets and generating outputs for conferences, publications, and regulatory submissions.
Key responsibilities include:
- Developing, validating, and maintaining SAS programs to create SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets from raw clinical databases
- Creating dataset specifications based on protocols and case report forms (eCRFs)
- Programming and validating Tables, Listings, and Figures (TFLs) for clinical study reports, interim analyses, and safety monitoring
- Performing routine statistical analyses including descriptive statistics, t-tests, ANOVA, and basic regression modeling
- Ensuring strict compliance with CDISC standards and internal SOPs
- Conducting independent double-programming validation for high-risk datasets
- Assisting in writing statistical methods and results sections for CSRs, abstracts, and manuscripts
- Managing multiple project timelines and urgent data requests simultaneously
- Collaborating with clinical research staff, principal investigators, data management, biostatisticians, and cross-functional teams
- Participating in process improvement activities and SOP development
Required skills include demonstrated SAS programming experience, knowledge of ICH Guidelines and FDA/European clinical trial regulations, exceptional organizational skills, meticulous attention to detail, and ability to work effectively in a fast-paced environment with shifting priorities. The role requires strong written and oral communication, ability to manage multiple tasks, and willingness to learn new techniques.