Scientist
Confidential
Thousand Oaks, CA
Full-time
Science
Posted on July 12, 2020
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; ANALYZING ADVANCED STATISTICAL ANALYSIS SYSTEM (SAS) ANALYSIS AND REPORTING SKILLS, INCLUDING SAS BASE, MACROS, AND SPECIFYING AND IMPLEMENTING SDTM, ADAM DATASETS, AND TFLS. TELECOMMUTING PERMITTED. Interested candidates mail resume to: HR Connect c/o TM Review @ Amgen Inc. 2202 N. Westshore Blvd., Suite 650, Tampa, FL 33607 Attn. Job #20516.271