SDTM Developer (Clinical Data Management)

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 2,700 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Office-based in Shanghai. One day per week working from home. 

Job Description

We are currently looking for a knowledgeable and proactive SAS Developer to join our global Data Management team.

Please note the official PSI CRO job title will be: Database Developer. If you are keen to provide the full range of clinical database development and programming services, ensure high quality, accuracy, and consistency of clinical data, and be involved in something new, outstanding and challenging, this job opportunity is perfect for you.

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

Qualifications

• 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

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 this is the right choice for you.