Therapeutics Inc.

• Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials in support of regulatory submissions and publications. • Generate SDTM datasets, ADaM datasets, and Define.xml or Define.pdf files. • Perform quality control for SAS programs and other study documents (e.g., presentations and reports). • Maintain complete and auditable documentation of all programming activities. • Review output across SAS programs to ensure consistency. • Provide statistical programming support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests. • Assist Clinical Data Managers with data review via SAS programmed data checks and listings. • Assist in programming, testing, and documenting SAS global utility programs and tools in accordance with standards and validation procedures. • Participate in the development and/or maintenance of departmental procedures and standards. • Review CRFs, edit check specifications, and table mock-ups. • Work collaboratively with cross functional groups, study team, and vendors. • May assist in creation of table, figure, or listing mockups under supervision of statisticians.