Biostatistical Programming Mgr
The Technical Manager will ensure that projects outsourced to our Functional Service Providers (FSPs) are aligned with our priorities and meet Amgen timeline, quality, data standards and compliance expectations. The Technical Manager will also provide technical consultancy to our FSPs on Amgen processes, tools and utilities.
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
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, and the Statistical Project Plan (SPP) for accuracy and completeness
Advise FSP SLP on study-specific questions for specifications, documentation, and coding
Lead/contribute to GSP continuous improvement initiatives
Master's degree and 3 years Statistical Programming experience
Bachelor's degree and 5 years Statistical Programming experience
Associate's degree and 10 years Statistical Programming experience
High school diploma and 12 years Statistical Programming experience
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
6+ years of statistical programming 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; 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
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
We are all deeply committed to our mission: to serve patients. And we all have opportunities to contribute to that mission in meaningful ways. This creates a powerful sense of shared purpose.
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.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.