• Follows Standard Operating Procedures (SOPs).
• Understands and implements current CDISC and other regulatory standards.
• Develops annotated CRFs.
• Applies knowledge of SAS programming to develop production SDTM and ADaM datasets for clinical trials data and for integrated summaries according to SAP and other specifications.
• Creates and maintains specifications for CDISC SDTM and ADaM datasets and other derived datasets.
• Develops the reviewer’s guide and define.xml files.
• Validates datasets using Pinnacle 21.
• Develops and implements internal SAS programming standards.
• Maintains documentation for SAS programs and validation results.
• Participates in SAS programming infrastructure development.
• Effectively communicates the statistical programming issues to project team in both written and verbal form.
• Helps coordinate programming activities with biometrics lead and other study programmers to meet timelines.
Additional Responsibilities (as needed):
• Participates in the development and review of database structures.
• Provides statistical programming and validation support for TFLs.
• Develops randomization schedules.
• Reviews and updates statistical and/or programming SOPs as necessary.
• Performs additional tasks as assigned.
• B.S. degree or higher in computer science, statistics, or related field.
• Expert-level skills in SAS programming, including ODS, SQL, MACRO, STAT, GRAPH, and ACCESS.
• Minimum 3 years’ experience with CDISC for clinical trials in the pharmaceutical industry, including developing SDTM and ADaM datasets, aCRFs, SDTM and ADaM mapping specifications, define.xml documents, and reviewer’s guides.
• Clear understanding of the drug development process, submission-related activities and regulatory requirements (eg, CDISC, CDASH, eCTD) and guidelines (eg, ICH, CHMP, FDA, GCP).
• Excellent written and verbal communication skills.
• Attention to detail.
• Good time management skills and the ability to work under extremely tight deadlines.
• Strong organizational skills.
• Ability to shift priorities.
• Sensitivity to and willingness to accommodate the needs of clients.
• Willingness to work closely and coordinate with other programmers and statisticians to ensure deliverables are met.
• Ability to adhere to standard operating procedures.
Remote or St. Petersburg, FL