Associate Director, Biostatistical Programming
5 hours ago
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
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