Biostatistical Programming Manager

Career Category

Job Description

Amgen focuses on areas of high unmet medical need leveraging its expertise to deliver innovative solutions that improve health outcomes and lives. Since 1980 Amgen has become one of the worlds leading biotechnology companies reaching millions of patients globally and developing a robust pipeline of novel medicines.

Observational research plays a critical role in drug development and commercialization as regulators and payers increasingly rely on real-world evidence (RWE) to guide decision-making. The Center for Observational Research (CfOR) at Amgen generates and applies RWE across the drug development lifecycle to further understand the nature of disease (frequency distribution clinical course) and the safety and effectiveness of medicines.

Amgen is seeking a Biostatistical Programming Manager to join CfOR in Japan. This role supports generating RWE through hands-on programming data management and generating reports based upon real-world data of health care. The programming manager will partner with epidemiologists and cross-functional teams across multiple time zones to oversee request fulfillment clarify requirements resolve issues and deliver high-quality outputs.

The ideal candidate holds a bachelors degree and has at least six years of relevant experience in statistical programming including postgraduate and doctoral research experience. Proficiency in SQL SAS and R programming is required. Strong scientific technical and communication skills; problem-solving; and ability to work effectively within a global team are essential.

Responsibilities:

• Develop test validate and execute programming code and macros that generate analysis datasets and tables listings and figures to support decision making in drug development
• Lead and develop technical programming and process improvement initiatives within CfOR
• Represent the programming team and collaborate with peers in clinical and epidemiology functions

• Manage all programming team activities and provide technical solutions to programming issues

• Ensure programming activities adhere to departmental standards and SOPs as well as local compliance and regulatory standards
• Write and review programming plans and dataset specifications
• Review key study-related documents including but not limited to statistical analysis plans (SAPs) and data management plans (DMPs)
• Lead in the development of departmental policies and controlled documents
• Respond to study and systems audits
• Participate in the recruitment and oversight of programming staff
• Actively participate in external professional organizations and conferences
• Contribute to the continuous improvement of programming processes

Basic Qualifications:

• Bachelors degree in Computer Science Statistics Mathematics Life Sciences Business Analytics or related field

AND

• At least six (6) years of relevant statistical programming systems engineering or application programming experience in a clinical development or life sciences setting including postgraduate and doctoral research experience

AND

• Managerial experience directly managing people or leadership experience leading teams projects programs or directing the allocation of resources in statistical programming projects

AND

• Experience in SQL and statistical programming using SAS and R

Preferred Qualifications:

• Masters degree in Computer Science Statistics Mathematics Life Sciences Business Analytics or relevant field
• Track record establishing analysis standards QC/QA processes and controlled change management.
• Experience or willingness to learn the process of delivering regulatory-grade analyses and submission-ready deliverables

• Foundational understanding of medical statistics (e.g. study design hypothesis testing propensity score methods).
• Experience working with real-world healthcare data (RWD) such as NDB and DeSC
• Team management
• Ability to communicate confidently and effectively across cultures
• Familiarity with cloud environments such as AWS EC2 and Databricks
• Proficiency in shell scripting and system operations in Linux
• Proficiency in Python