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Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products. Together with GPL, this Associate Director will be accountable and responsible for Global Statistical Programming study results and submission activities for the assigned products or indications across products. The Associate Director of Biostatistical Programming will contribute at the department level by leading major GSP technical or operational efficiency initiatives and ensuring compliance with R&D standards, leading or serving as a member of GSP and cross functional consultancy groups such as Submission Consultancy Group and ADaM Consultancy Group. The Associate Director will drive the piloting and integration of new technologies, including artificial intelligence, statistical programming automation tools, and open-source platforms to improve quality and efficiency across the organization.
Job Responsibility:
Accountable and responsible for ensuring successful execution and delivery of GSP milestone analysis deliverables and regulatory submission packages for a group of high priority and/or high complexity 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 products 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
Drive the piloting and integration of new technologies, including artificial intelligence, statistical automation tools, and open-source platforms to improve functional maturity and efficiency
Lead and/or participate in departmental process improvement initiatives and cross-functional working groups
Represent GSP 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 GSP staff globally
Provide input into career development plans to direct reports and staff on assigned projects
Requirements:
BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 10 years of statistical programming experience in clinical development environment
Strong technical, communication, and leadership skills
Ability to lead and manage a large team of programmers in successful and timely completion of all programming activities for highly complex studies and regulatory submissions
Experience developing a successful offshore statistical programming team
Flexibility and desire to work across different time-zones
Advanced analysis and reporting skills in SAS (including SAS/STAT, Macro, Graph, SQL, and others) or R
Prior regulatory submission experience for approval
Thorough understanding and experience with data quality and compliance checks
Experience working effectively in a globally dispersed team environment with cross-cultural partners
Prior staff development leadership and project management experience
Excellent oral and written English communication skills
Ability to effectively perform complex statistical programming and related tasks
Nice to have:
MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects
Familiarity with open-source programming tools (e.g., R, Python), automation platforms, and emerging technologies in statistical programming
What we offer:
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits