Statistical Assistant Jobs in Fairfield, CA (NOW HIRING)

The Associate Clinical SAS Programmer/Junior Statistician plays a pivotal role in the clinical trial lifecycle by transforming raw clinical trial data into formatted, analysis-ready datasets and generating the outputs required for, conference, publication, and regulatory submissions. The Associate Clinical SAS Programmer/Junior Statistician will interact well with the Heartflow Clinical Research staff and collaborate effectively with principal investigators to ensure that data structure, quality and reporting strictly adhere to industry standards and regulatory guidelines.  The Associate Clinical SAS Programmer/Junior Statistician will have demonstrated experience programming in SAS, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast-paced start-up culture. 

Job Responsibilities:

• Dataset Development & Mapping:  Develop, validate, and maintain SAS programs to create SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) datasets from raw clinical databases.
• Create and review dataset specifications based on the protocol, and case report forms (eCRFs).
• Draft and implement Statistical Analysis Plan (SAP) and create mock-up shells for Tables, Listings, and Figures (TFLs) under senior guidance.
• TFL Generation: Program, test, and validate Tables, Listings, and Figures (TFLs) required for Conferences, Publications, Clinical Study Reports (CSRs), Interim Analysis, Data Monitoring Committees (DMC), and safety monitoring.
• Perform routine statistical analyses (such as descriptive statistics, t-tests, ANOVA, and basic regression modeling) using SAS.
• Standards & Compliance: Ensure strict compliance with CDISC standards (SDTM/ADaM) and internal standard operating procedures (SOPs).
• Validation & Quality Control: Perform independent double-programming to validate high-risk datasets and statistical outputs, ensuring 100% accuracy and reproducibility of clinical trial results.
• Reporting and Interpretation: Assist in writing the statistical methods and results sections for Clinical Study Reports (CSRs), abstracts, and manuscripts. Prepare clear, concise summaries of statistical findings for internal project teams and clinical investigators.
• Effectively translate complex statistical requests from principal investigators and biostatisticians into programmatic solutions.
• Manage project deliverables to ensure they remain within the timeline and budget
• Develop timelines for programming.
• Participate in and lead process improvement activities within the department and cross functionally, including SOP development
• Work with other clinical research team members on study start-up activities including the development and review of case report forms.
• Manage multiple timelines, protocol amendments, and urgent data requests simultaneously.
• Meticulous approach to data quality and validation code.
• Maintain effective working relationships with principal investigators
• Work in coordination with Data Management, statisticians, programmer/analysts, clinical research team members, and other team members as required
• Perform other duties as required for successfully completing studies, as necessary

Skills Needed:

• Ability to work in a smaller team environment with a willing, all hands-on deck attitude
• Ability to manage multiple tasks and be comfortable working in an environment with shifting priorities
• High attention to detail, accuracy, and quality and able to effectively prioritize multiple projects
• Flexibility and willingness to learn new techniques and procedures to ensure the successful completion of projects
• Knowledge of ICH Guidelines, US FDA, and European clinical trial requirements and regulations
• Excellent written and oral English communication skills required
• Proficiency in computer programs and specifically in Microsoft office tools including Word, Excel, and PowerPoint;
• Ability to explain mathematical and statistical concepts to non-statistical team members (like clinicians and Clinical Trial Managers).
• Strong analytical mindset with high attention to detail in data trends and anomalies.
• SAS proficiency required: Advanced knowledge of Base SAS, SAS/STAT, SAS/GRAPH, SAS/Macro facility, and SQL.
• CDISC Standards: Hands-on experience implementing SDTM and ADaM models.
• Data Types: Familiarity with Electronic Data Capture (EDC) systems and clinical data structures
• Statistical Knowledge: solid understanding of core biostatistical methods (e.g., survival analysis, longitudinal data analysis, categorical data analysis).
• Experience transitioning or integrating Python code alongside SAS for modern clinical trial analytics a plus.

Educational Requirements & Work Experience: 

• Bachelor's degree in science or health related field
• Demonstrated 3-4 years minimum relevant experience required
• Experience in cardiovascular medical device clinical research a plus
• Experience in registry studies and investigator-initiated studies a plus

A reasonable estimate of the yearly base compensation range is $86,000 to $112,000 (for San Francisco Bay Area) OR $71,000 to $92,000 (for all other locations) and bonus. #LI-Hybrid