Clinical Data Analyst

SetPoint Medical’s Clinical Data Analyst will utilize their expertise in electronic data capture systems, data management, and statistical analysis to monitor, validate, analyze and interpret clinical data. Their skills will contribute to the generation of evidence to support the development of new medical devices that are safe and effective for patients.

The Clinical Data Analyst will develop and implement data analysis techniques, processes, and tools to ensure data accuracy and integrity. They will also analyze and interpret clinical data to identify trends, patterns, and insights. This individual is expected to compile and present regular reports about data being collected in ongoing studies, and translate the data into actionable intelligence for the trial clinicians and administrators. They will also play a key role in the development of tables, listings, and figures to support presentations, publications and regulatory submissions. This position will report to the Director of Clinical Affairs.

Job Responsibilities

Include but are not limited to the following:

• Establishing and managing Clinical Data Management (CDM) processes to ensure the coordination and standardization of data collection.
• Designing and implementing database systems and data collection workflows for all phases and activities of specific clinical investigations.
• Training and mentoring team members on data analysis tools and techniques.
• Preparing data management documents required for conduct of a study (such as Case Report Forms and Data Management Plans).
• Collaborating with data managers, statistical programmers, biostatistics, clinical operations, and external vendors to review, sign off on the data transfer specifications, and transfer data from external sources, ensuring data is received and validated for data integrity.
• Designing methods for conducting data quality checks and validations to ensure consistency and accuracy. Determine root cause of data-related issues and provide support to resolve them.
• Generating reports, dashboards, and visualizations to communicate data monitoring and analysis results.
• Collaborate in developing programming specifications and creating program-specific validation plans using established validation practices and processes.
• Providing insights and recommendations to stakeholders based on data analysis findings.
• Developing reports, charts, graphs and tables for presentations, publications and regulatory submissions.
• Contribute to data interpretation and study reporting (CSR) in collaborative fashion with other clinical development scientists/medical directors/cross-functional groups.

Minimum Qualifications

• Bachelor’s degree in computer science, mathematics, statistics, or a related field.
• Minimum of 5 years of experience in clinical data analysis or a similar role.
• Strong knowledge of data analysis tools, techniques, and methodologies.
• Ability to think critically and identify trends and patterns in complex data sets.
• Excellent communication and presentation skills to convey complex findings clearly.
• An understanding of data analysis concepts, including data types, data manipulation, data cleansing, and data quality assurance.
• An understanding of basic statistical concepts, such as measures of central tendency, variance, correlation, multivariate relationships, and regression analysis.
• Familiarity with the fundamental principles of data visualization, such as data encoding, visual perception, chart selection, and best practices for presenting data visually.
• Familiarity with clinical research protocols and terminology.
• Experience with data management principles and regulatory requirements for clinical trials and medical research.
• Working knowledge of GCP, GCDMP, Clinical and Regulatory Affairs.
• Proficiency in statistical software and programming languages (e.g., Stata, SAS).
• Experience using Electronic Data Capture systems.

Other Requirements

• Excellent problem-solving, analytical, and communication skills.
• Strong attention to detail and accuracy.
• Encourages continuous improvement and provides training to keep clinical departments current on best practices, regulatory requirements, etc.
• Self-motivated, flexible, able to prioritize and work in a fast paced and demanding environment.
• Takes ownership of a given assignment, proactively consulting project team members and other department representatives for information or guidance, as necessary.

Location

This is an in-house position at company headquarters in Valencia, CA. However, fully remote or hybrid work schedules will be considered and may require a probationary period arrangement.

Company Description

SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases with its neuroimmune modulation platform.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment.

We are proud to be an equal opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.