Biostatistical Programming Manager

Career Category

Business Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Biostatistical Programming Manager in Taipei, Taiwan.

Live

What you will do

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).

Win

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

 

Thrive

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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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