Accountable for developing programs to create SDTM for clinical trials for delivery to different internal groups and for submission to the regulatory authorities.
Perform CRF annotation, specification preparation, programming to create SDTM datasets, validation, and documentation.
Provide SDTM programming support to create standard reports & listings for submission and data review purpose.
Provide technical guidance to the SDTM team and the developers; technical design and development of tools and applications including clinical databases, reports, listings, etc. Develop external data transfer specification and executes data transfer(s).
Provide oversight/guidance to contractors and technical guidance to teams developing specifications.
Provide programming, troubleshooting and technical support for the whole study lifecycle (including external data load and extraction); provide end-user and application support and performs routine system administration activities; execute database and program maintenance; follow quality control methodologies and documentation requirements.
Required:
Bachelor’s degree in Computer Science, Computer Information Systems and Information Technology, or a closely related field plus 5 years of progressive, post-baccalaureate Data Operations methods and processes experience in industry setting in job offered or as Statistical Programmer Analyst/SAS Programmer Analyst.
Requires 3 years of experience using/with the following (which may have been gained concurrently)
Handling SDTM mapping both safety and efficacy domains for clinical trials, and programming to create SDTM data sets; Preparing annotated eCRF, mapping specifications, SDTM datasets, and Define.xml, and SDRG
SDTM validation using OpenCDisc / CDISC enterprise
Handling external data, e.g., laboratory data, PK, ECG, Tumor, etc.
Using SAS/Base, SAS Macros, SQL.;
Using MedDRA and WHO DRUG, ORACLE, EDC System, and InForm.
Job Type: Contract
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
Ability to Relocate:
- Nutley, NJ 07110: Relocate before starting work (Required)
Work Location: In person