Job responsibilities

– Develop specifications for analysis datasets in consultation with Biostatistician
– Follow the Study Data Tabulation Model (SDTM) Implementation Guide, write specifications for SDTM datasets
– Follow statistical analysis plans and the Analysis Data Model (ADaM) Implementation Guide, write specifications for analysis datasets
– Follow specifications, develop algorithms and write programs to create datasets
– Implement entire programming process
– Develop the programs using SAS to produce Tables, Listings, and Graphs asper the specifications indicated in Statistical Analysis Plan
– Implement installation of VCS client applications and/or plug-ins 
– Implement checkout, check-in, update, merge of the working copies
– Independently check data listings, summary tables and graphs
– Import and export SAS data
– Perform programming validation to assure accuracy, reliability and consistency
– Independently check data listings, summary tables and graphs 
– Import and export SAS data
– Assist data
management group in performing data edit checks
– Understand and conduct work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements
– Interact with the project statistician and guide other programmers participating on a project team

Required qualifications

– Bachelor’s or Master’s degree in Computer Science or a related field
– At least 1+ years relevant work experience
– Excellent English knowledge
– Strong sense of discipline and responsibility
– In-depth understanding of data collection, data flow management, data quality, data extraction and data standards (knowledge of CDISC standards for CDASH, SDTM and ADaM a plus)
– Experience with multiple programming languages (SAS programming language, R, SQL or other languages/tools as required, SAS Certification desired), including the creation of data entry and query screens/processes and data quality checks
– Experience in reports and query development, especially for data validation and data quality assessment; experience with electronic data capture (EDC) and database management systems (e.g., REDCap, Medidata, TrialMaster, Inform, etc.) In-depth knowledge of research processes, clinical operations, and data quality management
– Strong attention to detail and demonstrated proficiency in quantitative and qualitative analyses
– Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction
– Experience in training users in the operation of clinical trials software and tools
– Ability to exercise judgment, initiative, and resourcefulness in making decisions in consultation with clinical research personnel, and independently if necessary
– Demonstrated strong teamwork and organizational skills; outstanding interpersonal and communication skills