Clinical Data Scientist

vor 2 Wochen

Munich, Deutschland PSI CRO Vollzeit

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

**Job Description**:
Reporting to the Associate Director Risk-Based 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 Risk-based Monitoring systems in Process Improvement department.

**Project/ program assignments**
- Participate in selection of the Risk-Based Monitoring (RBM) system and provide relevant training to the project team and/or Sponsor
- Set up and maintain RBM systems in collaboration with Central Monitoring Manager
- Establish data extract, load and transformation process for a study. Manage large complex datasets (including unstructured data) coming from multiple data sources. Map, mine and classify raw data and pull processed data into PSI data platform
- Program and produce data listings, tables and figures for Clinical Data Reviewers and Central Monitoring Managers
- Collaborate with Central Monitoring Manger and cross-functionally to identify study challenges, develop an action plan and data solutions to address those using advanced analytics technics. Provide outputs actionable for project team
- Communicate and explain data findings and solutions to cross-functional stakeholders

**Corporate/ departmental assignments**
- Participate in development and programming of databases and software products for Centralized Monitoring
- Participate in development of processes, Quality System Documents (QSDs) and internal instructions for Centralized Monitoring

**Qualifications**:

- A degree in a Data Science, Mathematics, Statistics, Computer Science or equivalent or Data Science related work experience and professional qualifications
- At least 3-year experience or equivalent in Data Management, Biostatistics, and Centralized Monitoring
- At least 2-year experience with one or more of the following: R, Shiny, Python, Jupyter, SAS, SQL, Spark and associated packages and libraries (advanced knowledge of R-packages, RStudio, SAS and Excel is an advantage)
- At least 2-year experience in data management area including one or more of the following: relationship databases, data warehousing, data schemas, data stores, data modeling, testing, validation and analysis
- Knowledge of ELT/ETL process is a plus
- Experience with databases engineering and development is a plus
- Knowledge of statistical methods and techniques for analyzing data is a plus
- Experience with using Machine Learning technics is a plus
- Experience with Shiny development is a plus
- Experience with products testing and validation is a plus
- Strong analytical and logical thinking, focus on results
- Communication and collaboration skills
- Ability to work both independently and collaboratively within a team
- English skills (Advanced)

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. We have a generous benefits package here at PSI as we understand the importance of giving back to our employees. Our benefits are focused on providing you with the support to excel both at work, and in your personal life

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