Spotfire Advanced Administrator _ Clinical Data Analytics

Position Summary:

We are seeking an experienced Spotfire Advanced Administrator to support our GxP Spotfire platform and clinical study data analytics initiatives at Clinnex.

The ideal candidate will have deep hands-on experience with TIBCO Spotfire administration, configuration, automation, and data integrations, along with a strong understanding of clinical data domains (CDM, EDC, SDTM, IRT, CRO CTMS, Safety).

This role will be responsible for end-to-end management of the Spotfire platform, enabling advanced data analytics for Clinical Operations, Data Management, Biometrics, Biomarker Data Science, Clinical Development, and Safety teams.

The candidate will also work 1:1 with the Chief of Staff, Clinical Development, to manage new study setups, complex calculations, and data validation activities.

Key Responsibilities:

Spotfire Platform Administration

• Manage and maintain Spotfire Server and Automation Services across multiple environments (Test, Prod).
• Configure and manage data source connections (Oracle, Snowflake, SAS datasets, AWS Redshift, SQL Server, etc.).
• Implement and maintain library structures, groups, licenses, and permissions per data governance policies.
• Administer Spotfire upgrades, patches, and hotfixes ensuring stability and validated operation.
• Optimize dashboard performance and manage large datasets, caching, and data load strategies.
• Automate data refreshes, report scheduling, and job monitoring using Spotfire Automation Services or Job Scheduler tools.
• Collaborate with IT GxP teams to ensure compliance with GxP and 21 CFR Part 11 validation requirements.

Clinical Data Integration & Understanding

• Work closely with Clinical Data Management, Biostatistics, Clinical Operations, Biomarkers, and Safety teams.

• Strong understanding of clinical data domains:

• EDC (e.g., Veeva EDC)

• CTMS (CRO systems)
• SDTM and ADaM datasets
• Clinical operations metrics (enrollment, query resolution, monitoring progress)

• Safety data (AE, SAE, MedDRA coding)

• Support creation and validation of clinical dashboards (subject enrollment, site performance, data cleaning progress, safety summaries).

• Collaborate on building analytical datasets for regulatory reporting and oversight.

Collaboration & Governance

• Partner with Clinical Data Programmers, Safety Scientists, and Study Teams to develop and enhance analytics solutions.
• Maintain complete system documentation, configuration, validation, and change management per GxP standards.
• Provide user training, troubleshooting, and ongoing technical support to end users and developers.

Qualifications & Experience:

Required:

• Bachelors degree in Computer Science, Life Sciences, Data Analytics, or a related field.
• 15+ years of professional experience in Spotfire administration (Server, Analyst, Automation Services).
• Proven experience working with clinical study teams and clinical data.
• Deep understanding of EDC, SAS, SDTM, ADaM, and clinical operations data.
• Strong SQL skills and experience connecting to clinical databases (Oracle, Snowflake, SAS, etc.).
• Experience integrating Spotfire with R, Python, or SAS for advanced statistical analytics.
• Familiarity with GxP, 21 CFR Part 11, and validated system practices.
• Expertise in troubleshooting performance issues and managing large datasets efficiently.

Preferred:

• Experience with AWS or Azure environments for hosting Spotfire.
• Knowledge of RBM (Risk-Based Monitoring) dashboards and clinical data visualization templates.
• Prior experience in pharmaceutical, biotech, or CRO environments.

Must-Have Skills:

• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to collaborate effectively with cross-functional clinical and data teams (IT GxP, Clinical Data Management, Biometrics, Biomarkers, QA).
• Excellent communication, documentation, and stakeholder management skills.
• Self-motivated, detail-oriented, and capable of thriving in fast-paced environments.

Additional Information:

Work Hours: Must be flexible to work during U.S. time zones (Pacific or Eastern hours) as needed for collaboration with U.S.-based teams.