Associate Director, Biostatistical Programming

Key Responsibilities:

• 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

Basic Qualifications:

• 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

Preferred Skills:

• 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