PSI CRO AG is hiring a
SDTM Developer

Summary

Join our global Data Management team as a knowledgeable and proactive SAS Developer to provide clinical database development and programming services.

Requirements

• College or University degree (IT, programming, technical education)
• Sufficient relevant technical experience
• Experience in Clinical Data Management systems (like Medidata/Veeva) is desirable
• Knowledge of and experience in the SAS programming language (Base SAS, SAS/Macros, SAS/ODS)
• Knowledge of and experience in SQL
• Proficient user of standard MS Office applications and MS Access
• Experience in a professional environment, preferably with clinical or medical data

Responsibilities

• Communication point for data management and statistics on matters of database programming and deliverable database development
• Clinical database (EDC) requirements/structure review and testing
• Data validation plan review and programming of data validation procedures
• Generation of clinical database listings and reports to support clinical trial data collection, tracking, review and validation
• Programming of patient profiles
• Participate and support the development of Study Data Tabulation Model (SDTM) (define.xml, annotated CRF, reviewer’s guide) and programming of data transformation from raw data sources into CDISC-complaint deliverable
• Validation of clinical trial data according to SDTM specifications
• Deliverable database transfer to clients; electronic data transfers
• Liaison with vendors and clients regarding electronic data transfer specifications
• Receipt and validation of electronic data transfers