Reporting to the Associate Director RiskBased and Centralized Monitoring the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data develop new data solutions and set up Riskbased Monitoring systems in Process Improvement department.
Hybrid work in Sofia
- Participate in selection of the RiskBased Monitoring (RBM) system and provide relevant training to the project team and/or Sponsor
- Set up and maintain RBM systems collaborating with the Central Monitoring Manager
- Manage complex datasets from multiple sources including data extraction transformation and loading into PSI data platform
- Program and produce data listings tables and figures for Clinical Data Reviewers and Central Monitoring Managers
- Calculate Key Risk Indicators and Quality Tolerance Limits applying advanced analytical techniques to identify data trends for Centralized Monitoring
- Collaborate crossfunctionally to identify study challenges and develop data solutions using advanced analytics
- Communicate data findings and solutions to stakeholders effectively
- Contribute to the development of databases software products processes and Quality System Documents for Centralized Monitoring
Qualifications :
Must have:
- Degree in Data Science Mathematics Statistics Computer Science or equivalent; or relevant work experience and professional qualifications
- At least 3 years of experience in Data Management Biostatistics and Centralized Monitoring
- At least 2 years of experience in SAS and at least one of the following: R Python Jupyter SQL Shiny Spark and associated packages and libraries
- Full professional proficiency in English and Bulgarian
- Strong analytical an logical thinking
- Communication and collaboration skills
Nice to have:
- Experience with CluePoints RBM system and ELT/ETL processes
- Knowledge of statistical methods data analysis and Machine Learning techniques
- Experience with database engineering products testing and validation and Shiny development
Remote Work :
No
Employment Type :
Fulltime