About this role
Job title: Senior Manager, Biostatistical Programming
About the Role Amgen is expanding its Global Statistical Programming capabilities, with Amgen India playing a key role in delivering across regions. As Senior Manager of Biostatistical Programming, you will partner with the Global Programming Lead and lead an offshore team to ensure successful end-to-end programming activities and regulatory submission readiness for assigned product areas. You will be accountable for Global Statistical Programming study results and drug approval submission activities for the assigned product areas.
What You'll Do
- Accountable and responsible for ensuring successful execution and delivery of Global Statistical Programming milestone analysis deliverables and regulatory submission packages for a product, or group of Amgen products, being supported by the offshore programming team.
- Work with GPL to ensure successful implementation of programming strategies, such as functional standards and industry requirements for the assigned product globally.
- Plan and monitor progress of projects and address issues accordingly.
- 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 other controlled documents affecting GSP globally.
- Provide hands-on support to the assigned product areas as required.
- Provide coaching and mentoring to local programming staff.
- Provide input into career development plans for all staff on assigned projects.
What We're Looking For
- We are all different, yet we all use our unique contributions to serve patients.
- The professional we seek is a results-oriented.