Biostatistical Programming Manager

Biostatistical Programming Manager

Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen Taiwan playing a key role in supporting integrated delivery across regions. As a Biostatistical Programming Manager, you will serve as the Study Lead Programmer (SLP) for one or more studies and lead a team of statistical programmers to support all statistical programming activities within a study. You may also support regulatory submissions.

Key Responsibilities

• Lead one, or more than one, study/project end to end and assume all the responsibilities of Study Lead Programmer

• Set the programming strategy for the studies and projects and ensure timelines, quality, and compliance of all deliverables

• Lead and manage specific programming tasks (e.g., all programming related activities of an integrated analysis that involves multiple studies for regulatory submissions) assigned to the team

• Participate in establishing the programming scope for a deliverable with statisticians and study team

• Participate in establishing detailed timelines that will ensure timely delivery of programming deliverables for a study or project

• Create and maintain programming related specifications (e.g., SDTM and ADaM) for the studies/projects

• Representing GSP at the Clinical Study Team (CST)

• Attend meetings for, and provide programming input into, cross-functional study start-up activities, including but not limited to CRF development, database specifications review, database development, IVRS specification review, data quality check specifications

• Initiate cross-functional team meetings as necessary

• Perform significant hands-on statistical programming, particularly for those most challenging deliverables

• Manage individual programmer work assignments to ensure timely, high-quality deliverables

• Provide technical leadership and guidance for study programming team

• Coordinate and monitor data issue reporting and resolution

• Coordinate with other SLPs to provide consistent deliverables across studies within a product

• Manage technical aspects of project (e.g., create/manage computing environment, lookup tables, etc.)

• Provide training and guidance to other programmers

• Assume some product level responsibilities as delegated by Global Programming Lead (GPL) and/or Programming Execution Lead (PEL).

• What we expect of you

Basic Qualifications:

• BA/BSc or higher degree in biostatistics, statistics, mathematics, computer science, or other related quantitative or scientific subjects, with at least 5 years of statistical programming experience in clinical development environment.
• Thorough understanding of clinical trial processes, from data collection to analysis reporting
• Proven record of superior statistical programming and problem-solving skills within clinical development environment
• Prior experience and ability to lead and manage statistical programmers in successful and timely completion of all programming related activities (including preparing data and programming specifications) for a study end-to-end
• In-depth knowledge on latest CDISC SDTM, ADaM, and Define standards along with strong ability to implement all aspects of those standards
• Advanced analysis and reporting skills in SAS and/or R, including SAS/STAT and/or R packages, among others
• Experience in data quality and compliance check tools
• Excellent project management skills and ability to lead multiple projects effectively
• Excellent oral and written English communication skills
• Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners
• Willingness and ability to provide guidance to team members on technical and process questions

Preferred Skills:

• MSc or higher degree in statistics, biostatistics, mathematics, or related quantitative or scientific subjects

• Familiarity with open-source programming tools (R, Python), automation platforms, and emerging technologies in statistical programming

• Prior regulatory submission experience for drug approval

• What you can expect of us

• As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• 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