Description
Responsibilities:-Generate analysis datasets, tables, figures, and listing to support the analysis of clinical trials data
-Generate SDTM domains, ADaM datasets, and Define .xml files
-Perform quality control for SAS programs and other study documents
-Document the quality control review process
-Review output across programs to ensure consistency
-Review, maintain, and approve study documents per standard procedures
-Provide programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests
-Program, test, and document global utility programs and tools in accordance with standards and validation procedures.
-Provide technical oversight and leadership in areas of analysis and reporting
-Participate in the developement and maintenance of departmental procuedires and standards
-Review CRFs, edit check specification, and table mock-ups
-Assist in creation of table mockups under supervision of statsiticians
-Serve as the primary project team representative, delgating work as appropriate
-Train and mentor new programmers
Desired Experience:
-BS degree in Statistics, Mathematics, Computer Science, or related field
-Minimum 5 years Biotechnology/Pharmaceutical/CRO industry experience as a clinical trial SAS Programmer
-Demonstrates extensive knowledge with industry standards, such as ICH guidelines, CDISC, 21 CRF part 11, and FDA guidelines
-Excellent organizational skills, time management, and ability to coordinate workload to meet the established dealines
This is a great opportunity to not only be apart of the Statistical Programming team, but to provide your technical extertise to the developement of new treatments for patients. To be considered for an interview please contact me immediately and send over your updated resume. I look forward to discussing this opportunity with you further.
Best,
Joyce
Keywords:
SAS, Statistics, Statistical Programmer, CRF, CDISC, FDA, Biotechnology, Pharmaceutical, CRO, ICH, SAS Programming, Clinical Trials