Biostatistical Programming Senior Manager

Job Description Biostatistical Programming Senior Manager Live What you will do Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate. The Biostatistical Programming Senior Manager (Product Lead Programmer) lead a group of Oncology and other therapeutic area products. This Senior Manager will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned product areas. Accountable and responsible for Global Statistical Programming (GSP) study deliverables and submission activities for a group of Amgen products. Set and drive forward the programming strategies such as functional standards and industry requirements for the assigned product areas globally. Plan and monitor progress of projects and address issues accordingly. Support GSP Functional Service Provider (FSP) relationship and oversight; Ensure the product goals can be met via the FSP staff. Provide GSP product level input to developing and managing resource plans and budgets for GSP. Efficiently and effectively monitor and utilize assigned staff at product level according to priorities. Lead and/or participate in departmental process improvement initiatives and cross-functional working groups. Assist in study and system audits and inspections by internal and external bodies. Develop, review, and implement Policies, SOPs and othe