Career Category

Job Description

• Biostatistical Programming Manager – Technical Manager

  Amgen Global Statistical Programming (GSP) department is looking for an experienced Biostatistical Programming Manager to conduct the oversight of projects outsourced to our Functional Services Providers (FSP)

  The Role:

  As a Technical Manager, you will ensure that projects outsourced to our Functional Service Providers are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. You will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.

  Responsibilities

• Oversee the execution and quality of projects managed by our FSPs per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)
• Align FSP assignments with Amgen Development priorities
• Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations
• Contribute to FSP training material development and revisions, and conducting the initial training to FSP staff as needed
• Provide guidance and technical consultancy to FSP Study Lead Programmers (SLP) on Amgen processes, tools, and utilities
• Contribute to FSP performance metrics development, data collection, and reporting
• Review project documentations such as specifications, issue logs, deliverable status, for accuracy and completeness
• Advise FSP SLP on study-specific questions for specifications, documentation, and coding
• Lead/contribute to GSP continuous improvement initiatives

Basic Qualifications:

• BA/BSc in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subjects
• At least 6 years of statistical experience in biopharmaceutical industry
• Thorough understanding of clinical trial processes from data collection to analysis reporting
• Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions
• Experience working in a globally dispersed team on Phase 1-4 clinical trials
• Excellent oral and written English communication skills
• Advanced SAS analysis and reporting skills including SAS Base, macro, SQL, and STATS
• Hands-on experience in specifying and implementing SDTM and ADaM datasets and generating tables, figures, and listings

Preferred Qualifications:

• MSc in Computer Science, Statistics, Mathematics, Life Sciences or another relevant scientific subject
• Regulatory submission experience
• Vendor and resource management experience
• Familiarity with other programming languages such as R or Python
• In-depth knowledge of SAS/Graph and Stat packages
• Thorough understanding of data compliance checks such as Pinnacle 21
• Thorough understanding of clinical trial processes from data collection to analysis reporting
• Ability to lead programmers in successful completion of all study programming activities and provide guidance on technical and process questions
• Experience working in a globally dispersed team on Phase 1-4 clinical trials
• Excellent oral and written English communication skills; strong negotiation skills
• Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
• Hands-on experience in specifying and implementing SDTM and ADaM data sets, and TFLs
• Location: Shanghai, China
• Remuneration:  Competitive salary & comprehensive benefits package including bonus scheme

The company:

Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion annually and approximately 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patients. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and supporting services to deliver these exciting therapies to medical teams around the world.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.