About this role
About the Role Amgen is expanding its Global Statistical Programming capabilities, with Amgen India playing a key role in supporting delivery across regions. As Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads and lead a large offshore team of Study Lead Programmers and Study Programmers to execute end-to-end programming activities for studies and global regulatory submissions for high-priority products. You will be accountable for study results and submission activities, contribute to department-level initiatives, and drive adoption of new technologies to improve quality and efficiency.
What You'll Do
- Accountable for execution and delivery of milestone analyses and regulatory submission packages for high-priority and/or high-complexity Amgen products supported by the offshore programming team.
- Work with Global Programming Leads to implement programming strategies aligned with functional standards and regulatory requirements globally.
- Plan and monitor progress of projects; address issues accordingly.
- Provide product-level input to developing and managing resource plans and budgets.
- Efficiently monitor and utilize assigned staff at product level according to priorities.
- Lead major technical or operational efficiency initiatives and ensure compliance with R&D standards.
- Lead or serve as a member of Submission Consultancy Group and ADaM Consultancy Group.
- Drive piloting and integration of new technologies, including AI, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization.
What We're Looking For
- Experience leading large offshore programming teams and delivering end-to-end programming for studies and regulatory submissions.
- Strong collaboration with Global Programming Leads and cross-functional groups; ability to influence programming strategies globally.
- Proficiency in regulatory submission processes and knowledge of ADaM standards; ability to map strategies to industry requirements.
- Demonstrated ability to pilot and adopt new technologies, including AI and automation tools, to improve quality and efficiency.
- Excellent leadership, communication, and project-management skills.
Nice to Have
- Experience with AI and programming automation tools and open-source platforms.
- Familiarity with Submission Consultancy Group and ADaM Consultancy Group.
Compensation & Benefits Salary and benefits information not disclosed in the job posting.