Responsibilities / Authorities
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.
Review clinical data for outliers, invalid and illogical data points.
Interact with Clinical Data Management (CDM) to resolve data issues.
Must be able to use Univariate’s, frequencies, Proc Transpose, and macros, including modifying existing macros and writing macros.
Follow all pertinent SOP’s and guidelines concerning programming and the change control management of all files generated by the Biometrics Programming group.
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.
Write and compare independent QC programs to verify the output generated for data displays.
Coordinate QC project teams on large projects, which includes training and delegation of QC work.
Create and maintain standard QC documentation.
Maintain tables and listings binders, if applicable, which include a hard copy of the latest versions sent to the client.
Send tables and listings to clinical writers and clients, which include printing, collating, and filling out appropriate shipping paperwork.
Attend both client and team meetings when needed.
Respond to non-statistical questions from Clinical Writing and from clients.
Assist in establishing departmental processes, interaction with other departments, training of staff, and other departmental administrative tasks.
Experience on PC platform.
Proficient in at least one computer language, i.e., i.e., SAS, Oracle database programming, C
Proficient in at least one computer language, i.e., i.e., SAS, Oracle database programming, C++, FORTRAN.