- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, 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 documentatio...

- 6 month remote potentially renewable contract; must be able to work pacific time zone hours CDISC experience required NDA submission big plus • Generate analysis datasets, tables, figures, and listings to support the statistical analysis of clinical trials .data in support of regulatory submissions and publications. • Generate SDTM domains, 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 documentatio...

The Lead Biostatistician for product facing work is responsible for leading statistical activities of clinical studies. Works closely with cross-functional team members to ensure their clinical studies are appropriately planned, have the required statistical power for success, comply with Regulatory requirements and Amgen standards, and maintain statistical, as well as operational, integrity throughout the life of the study. Works closely with the Global Statistical Lead to ensure their study aligns with the overall product strategy. Also works closel...