What are the responsibilities and job description for the Spotfire Developer - Clinical, PK/PD & Safety Analytics position at Core Software Technologies Inc.?
Spotfire Developer to work onsite with one of our pharmaceutical clients in New Jersey. In this role, you will design, build, and maintain TIBCO Spotfire dashboards and analytic applications that clinical, biostatistics, real-world evidence (RWE), PK/PD, and pharmacovigilance (PV) and safety teams rely on to interpret trial, exposure-response, and safety data. You will work directly with the clients data management, clinical pharmacology, and drug safety teams within a regulated, GxP-aware environment.
Key Responsibilities:
- Design, build, and maintain TIBCO Spotfire dashboards and analytic applications for clinical trial and real-world evidence data.
- Connect Spotfire to SQL, SAS, and cloud-based data sources; structure and model data aligned to CDISC SDTM/ADaM standards.
- Write IronPython scripts and custom expressions to extend Spotfire functionality and automate recurring workflows.
- Partner directly with biostatisticians, data managers, and clinical programmers to translate analysis requirements into clear, usable visualizations.
- Optimize dashboard performance for large longitudinal and real-world evidence datasets.
- Support data validation, documentation, and change-control practices consistent with GxP expectations.
- Troubleshoot data connectivity, refresh, and rendering issues across Spotfire applications.
- Build and maintain PK/PD analytics dashboards and visualizations — exposure-response curves,concentration-time profiles, and dose-response summaries.
- Develop pharmacovigilance (PV) and safety analytics dashboards for adverse event review, signal detection, and safety monitoring across studies.
- Script custom PK/PD and safety data transformations and calculations (e.g., AE listings, SAE line listings, MedDRA/WHO-DD coded summaries) within Spotfire using IronPython.
Required Qualifications:
- 3–5 years of hands-on experience developing production Spotfire applications, ideally within a life science or CRO environment.
- Strong SQL skills and hands-on experience with IronPython or Python for scripting within Spotfire.
- Working knowledge of clinical data structures (CDISC SDTM, ADaM) or real-world healthcare data.
- Experience building PK/PD analytics and visualizations (exposure-response, concentration-time, dose-response) in Spotfire.
- Experience with pharmacovigilance and safety analytics — AE/SAE review, signal detection dashboards,and safety monitoring reporting.
- Hands-on scripting experience (IronPython/Python) to support PK/PD and safety/PV data transformations within Spotfire.
- Comfort working directly with client stakeholders in a regulated, GxP-aware environment.
- Bachelors degree in life sciences, computer science, statistics, or a related field.
- Strong written and verbal communication skills.
- Ability to work onsite in New Jersey, full-time.
- Eligible to work in the United States.
Preferred Qualifications:
- TIBCO Spotfire consultant-level certification.
- Experience working in 21 CFR Part 11 validated systems.
- Familiarity with R, Snowflake, or AWS-based data pipelines.
- Prior experience embedded directly at a pharmaceutical or CRO client site.
- Exposure to non-compartmental analysis (NCA) or population PK/PD outputs feeding into Spotfire visualizations.
- Familiarity with safety data standards (MedDRA, WHO-DD) and standard safety outputs (AE tables,SAE listings, DSUR/PBRER-style summaries).