| Job Description: | - Beginning SAS programmer who should have a clear understanding of clinical database structure and be able to produce basic
information from that database.
− Assist in establishing departmental processes, interaction with other departments, training of staff, and other departmental
administrative tasks.
− Respond to non−statistical questions from Clinical Writing and from clients.
− Attend both client and team meetings when needed.
− Send tables and listings to clinical writers and clients, which includes printing, collating, and filling out appropriate shipping paperwork.
− Maintain tables and listings binders, if applicable, which includes a hard copy of the latest versions sent to the client.
− Create and maintain standard QC documentation.
− Coordinate QC project teams on large projects, which includes training and delegation of QC work.
− Write and compare independent QC programs to verify the output generated for data displays.
− Program routine data displays, such as data listings, in accordance with approved statistical analysis plan and shell displays for clinical
research studies. Code is to be written using Base SAS programs, SAS procedures, or standardized macros. Perform data checks as
needed to understand structure and content of data.
− Follow all pertinent SOP’s and guidelines concerning programming and the change control management of all files generated by the
Biometrics Programming group.
− Must be able to use univariates, frequencies, Proc Transpose, and macros, including modifying existing macros and writing macros.
− Interact with Clinical Data Management (CDM) to resolve data issues.
− Review clinical data for outliers, invalid and illogical data points.
− Create and/or annotate and review tables and listings mocks; ensure internal consistency within and among tables and listings; ensure
that all CRF fields are displayed on listings. |
