Clinical Database Programmer (SDTM)

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

Project/ program assignments

• Develop the mapping of raw clinical data to a data structure compliant with CDISC standards, similar to SDTM, and perform data transformation programming (please provide details of your experience with these activities in the application)
• 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
• Calculate Key Risk Indicators and Quality Tolerance Limits. Apply advanced analytical technics to identify data trends and patterns for Centralized Monitoring
• 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 the Clinical Trials industry, in fields like Data Management, Biostatistics, or Centralized Monitoring is a must
• At least 2 years’ experience in CDISC standards, SDTM in particular is a must
• At least 2-year experience with one or more of the following: R, R Studio, R Shiny, Excel, Python, SAS, SQL and associated packages and libraries. 
• At least 2-year experience in data management area including one or more of the following: relationship databases development, data warehousing, data schemas, data modeling, testing, validation and analysis
• Knowledge of ELT/ETL process is a plus
• Knowledge of statistical methods and techniques for analyzing data is a plus
• Experience with R Shiny development is a plus
• Experience with products testing and validation is a plus
• Strong analytical and logical thinking, focus on results
• Experience with using Machine Learning technics is a plus 
• Ability to work both independently and collaboratively within a team
• Advanced English

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.