职位描述:
Job Description:
This is an advanced Senior Programmer Analyst or Programming Manager level position. Key respoibilities and skills may include, but are not limited to:
·Programming edit checks for Data Management with SAS;
·Create tables, listings and figures for clinical study report;
·Create blankcrf.pdf following FDA/CDISC or spoor guidelines;
·Create or QC SDTM specificatio and SDTM datasets;
·Create or QC ADaM specificatio and ADaM datasets;
·Create define.xml or define.pdf following FDA/CDISC or spoor guidelines;
·Serve as project lead programmer or team lead for the programming group;
·Awer technical questio; Resolve or solve technical problems;
·Work with global team or spoo to coordinate project deliverables, timelines and resources;
·For Programming Manager, manage programming team;
·Be a role model for team membe;
Requirements:
·Bachelor’s degree in computer science, statistics or related scientific disciplines with 4 year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 3 year of clinical programming experience
·Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
·Good undetanding of clinical drug development process.
·Detail oriented;
·Strong communication skills and coordination skills;
·Can communicate with global team with minimum supervision;