Biostatistical Programming Manager #20516.611
Amgen Inc.
Biostatistical Programming Manager Thousand Oaks, CA: Define and implement end-to-end programming and related submissions strategy for the product, and provide technical expertise and product-level programming leadership. Providing technical consultancy to Functional Services Provider (FSP) on processes, tools, utilities and contribute to FSP training material development and revisions; develop strategies to ensure deliverables outsourced to FSP are aligned with stakeholder priorities and meet timeline, quality, data standards, and compliance expectations; representing statistical programming team in audits and regulatory meetings, support in responding to audit/regulatory questions and findings; implementing solutions to develop product-level infrastructure, including design, development, validation, documentation, and maintenance of utilities and product level datamarts; and analyzing advanced Statistical Analysis System (SAS) analysis and reporting skills, including SAS base, macros, and specifying and implementing SDTM, adam datasets, and TFLS. Any suitable combination of education, training and experience is acceptable.
We are an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of race, color, national origin, religion, gender, age, veteran status, political affiliation, sexual orientation, marital status or disability (in compliance with the Americans with Disabilities Act) with respect to employment opportunities.