CDM Programmer- II (Spotfire)

Work Schedule

Environmental Conditions

Job Description

Join Us as a CDM Programmer II Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

We are seeking a highly skilled DM/Safety Review/Medical Review/Central Monitoring Programmer with expertise in TIBCO Spotfire and JReview (J-Review) along with strong clinical domain knowledge to design develop and support interactive dashboards for clinical data review and safety monitoring. The role involves close collaboration with cross-functional teams to deliver high-quality compliant and insight-driven visualizations for clinical decision-making.

Key Responsibilities

• Design develop and maintain complex Spotfire JReview allied analytics tool dashboards for clinical data review
• Perform data wrangling and transformation using Spotfire Data Canvas/Jreview/Python etc.
• Implement data-on-demand solutions and optimize dashboard performance for large datasets
• Translate clinical and business requirements into intuitive analytical dashboards
• Develop automated QC visualizations and standardized reporting solutions for global clinical trials
• Create and manage information models data connections information links and data functions
• Utilize IronPython HTML and scripting to enhance dashboard functionality
• Support users in creating and modifying dashboards and integrating data from multiple sources
• Perform troubleshooting debugging and performance tuning of Spotfire applications
• Ensure compliance with clinical data standards (SDTM) and regulatory requirements
• Collaborate with stakeholders to define timelines deliverables and project expectations
• JReview (J-Review) for clinical data review and visualization
• Must have understanding or hands on experience of Clinical domain drug development process (Phase I through IV) Clinical Data Management.
• Must open to learn new data analytics tools to develop medical safety and allied dashboards.
• Able to understand Python codes used for data preparation/wrangling.

Clinical Data Integration and Understanding

• Understand key clinical data domains: EDC (e.g. Veeva EDC) CTMS (CRO)
• SDTM datasets
• Clinical operations metrics (enrollment query resolution monitoring)
• Safety data (AE SAE MedDRA coding)
• Partner with Safety reviewers Medical data reviewers Central Monitors Clinical Data Management Biostatistics 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).
• Able to perform requirement gathering development and validation of GxP dashboards following industry and regulatory best practices.

Education and Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 4 years).

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:
Solid written verbal and computer skills
Solid attention to detail and problem solving skills
Solid organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
Basic experience in one or more programming languages or relational database systems (RDBMS) and structure
Working knowledge of programming tools SAS SQL Crystal Reports and JReview
Demonstrated skill in identification and resolution of technical problems in a professional environment
Capable of attaining maintaining and applying a working knowledge of GCPs and applicable SOPs
Demonstrated leadership ability and ability to work on a multi-disciplinary project team
Demonstrated initiative and motivation
Excellent project management skills such as project budget creation including modifying for project updates and managing project budgets and risks
Capable of interpreting and contributing to company policies
Delivery and quality driven

Working Conditions and Environment:
Work is performed in an office environment with exposure to electrical office equipment.
Occasional drives to site locations with occasional travel both domestic and international.


Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.