• Participate in database design, user requirement definitions and updates, representing data management comprehensively from data acquisition through the data reporting study lifecycle.
• Review CRF annotations and database data specifications ( EDC data as well as all other external data sources) to prepare for downstream programming activites (i.e SDTM, ADaM, TLFs) by the statistical programming group.
• Interface with data management and the study team to identify and program edit checks, data review listings, patient profiles per the Data Validation Plan/Data Management Plan using SAS and/or other software.
• Advise on the development of database quality standards including the oversight of standard eCRF library and version control processes, and on general programming standards.
• Participate in study team and some project team interactions. Builds successful relationships and seamlessly interfaces at the protocol/project team level. Provides timely and effective communication to the data management, programming and statistics leads. Collaborates with other study team members on timelines and project deliverables.
• Write SAS programs to generate or validate tables, listings, and figures and analysis datasets as needed.
• Consistent with programming standards, provide guidance to vendor or CRO within area of responsibilities.
• Help to develop, implement and promote efficient workflow for data management and programming processes.
Bachelor’s Degree in a related quantitative discipline and a minimum of 5 years of clinical programming experience in the Pharmaceutical, Biotechnology, or Contract Research Industry.
Additionally, the successful candidate must minimally possess distinguished abilities in the following:
• Experience with EDC (e.g. Open Clinica, RAVE, Inform, TrialMaster, etc.)
• SQL proficiency a plus
• Experience with SAS/BASE, SAS/Macro, SAS/GRAPH and the SAS Output Delivery System (ODS) required
• Working experience with CDISC CDASH and SDTM model
• Knowledge of:
o Relational Databases.
o Good Clinical Practices.
o Good Programming Practices.
o 21CFR Part 11 Standards.
• Experience working with CROs and vendor oversight.
• Excellent verbal and written skills, good organizational, interpersonal, and team skills.
• Ability to interact effectively with various functions such as Clinical Operations, Medical, Data Management, Statistical Programmers and Biostatistics.
• Ability to handle multiple tasks and to prioritize. Strong organizational and project management skills.
The candidate will report to the Director of Programming and will work closely with Statisticians/Statistical Programmers/Data Management, Clinical Operations and Development personnel.Apply Online