Job Description
We are seeking an experienced Spot fire Advanced Administrator to support our current GXP Spot fire, Clinical study data analytics and visualization at IDEAYA. The ideal candidate will have a deep understanding of clinical data domains (CDM, EDC, SDTM, IRT, CRO CTMS , Safety), along with hands-on experience in TIBCO Spotfire configuration, automation, user management, and data source integrations. The role will be responsible for managing the Spot fire platform, enabling analytics for clinical operations, data management, biometrics teams, Biomarkers, Clinical development and Safety scientists. This position will collaborate closely on 1:1 basis with Chief of Staff ClinDev and associated staff for new study requirements (loading, testing, developing complex calculations etc)
Key Responsibilities:
Spot fire Platform Administration
• Manage and maintain Spot fire Server, and Automation Services across environments (Test, Prod).
• Understand and configure data source connections (e.g., Oracle, Snowflake, SAS datasets, AWS Redshift, SQL Server).
• Implement and maintain library structures, groups, licenses (Analyst, Developer), and permissions according to data governance policies.
• Administer Spot fire upgrades, patches, and hotfixes, ensuring system stability and performance.
• Optimize performance of dashboards and analyses (complex calculations), including data load and caching strategies.
• Automate data refreshes and report scheduling using Spot fire Automation Services or Job Scheduler tools.
• Collaborate with IT GXP team to ensure compliance with GxP and validation requirements.
Clinical Data Integration and Understanding
- Understand key clinical data domains:
- EDC (e.g.Veeva EDC), CTMS ( CRO)
- SDTM and ADaM datasets
- Clinical operations metrics (enrollment, query resolution, monitoring)
- Safety data (AE, SAE, MedDRA coding)
- Partner with Clinical Data Management, Bio-statistics, and Clinical Operations to build and maintain analytical datasets.
- Support the creation and validation of clinical dashboards (e.g., subject enrollment, site performance, data cleaning progress).
Collaboration & Governance
• Work closely with IT Programmers, Clinical/EDC data programmers, safety scientists, and study teams to develop prototypes based on business requirements.
• Document system configuration, change management, and validation records to meet CFR 21 Part 11 compliance.
• Provide user support, troubleshooting, and training to end-users and other IT Clinical developers.
Requirements
Qualifications & Experience:
Required:
• Bachelor’s degree in Computer Science, Life Sciences, Data Analytics, or related field.
• 15+ years of experience with Spot-fire administration (Server, Analyst, Automation Services).
• Experience in clinical data environments — 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 Spot-fire with R, R Shiny Python, or SAS for advanced analytics.
• Familiarity with GxP, 21 CFR Part 11, and validated system practices.
• Proven ability to troubleshoot performance issues and manage large datasets.
Preferred:
• Familiarity with AWS/Azure environments for hosting Spot fire.
• Experience with RBM dashboards and clinical data visualization templates.
Must Have Skills:
• Strong analytical, troubleshooting and problem-solving skills.
• Ability to collaborate with cross-functional teams (IT GXP, Clinical (CDM, Biometrics),Biomarkers Data Science, QA).
• Excellent communication and documentation skills.
• Self-motivated and detail-oriented, with an ability to operate in fast-paced environments.
Requirements
Technical Competencies Required Skills (Must Have) Security Operations: · 3-5 years experience in SOC, threat detection, or incident response · Proficiency with SIEM platforms (Splunk, ArcSight, QRadar, or similar) · Hands-on experience with EDR solutions (CrowdStrike, Microsoft Defender, SentinelOne) · Strong understanding of security frameworks (MITRE ATT&CK, NIST Cybersecurity Framework) · Knowledge of incident response processes and procedures · Experience with security monitoring tools and techniques Technical Knowledge: · Strong understanding of networking (TCP/IP, DNS, HTTP/HTTPS, VPN, firewalls) · Windows and Linux system administration fundamentals · Knowledge of common attack vectors and threat landscape · Ability to read and interpret logs (Windows Event Logs, Syslog, firewall logs, web logs · Understanding of malware analysis concepts (static vs. dynamic analysis) · Basic scripting knowledge (Python, Bash, or PowerShell) for automation tasks Analytical Skills: · Excellent analytical and problem-solving abilities · Strong attention to detail and accuracy · Ability to work through complex investigations methodically · Data-driven decision making · Pattern recognition and anomaly detection capabilities Communication & Documentation: · Excellent written communication for incident reports and escalations · Ability to clearly explain technical findings to non-technical stakeholders · Strong documentation and note-taking practices · Clear verbal communication with team members and other departments Desired Skills (Nice to Have) · Threat Intelligence: Experience consuming and applying threat intelligence · Advanced Forensics: Digital forensics or malware analysis experience · Automation: Experience with Python, Ansible, or similar for playbook automation · Cloud Security: Experience with AWS, Azure, or GCP security monitoring · Certifications: GIAC Security Essentials (GSEC), CEH, Security+, CISSP, or similar · Incident Response: Prior incident response team experience · Vulnerability Management: Experience with vulnerability assessment and remediation · Compliance: Knowledge of compliance frameworks (PCI-DSS, HIPAA, SOC 2, ISO 27001)
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