Amgen is looking to solve the problem of ensuring all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate, in order to serve patients living with serious illnesses.
Requirements
- Masters 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
- Advanced SAS analysis and reporting skills including SAS Base, macro, and SQL
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
- 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
Other
- Doctorate degree OR Master’s degree and 2 years of statistical programming experience OR Bachelor’s degree and 4 years of statistical programming experience OR Associate’s degree and 8 years of statistical programming experience OR High school diploma / GED and 10 years of statistical programming experience
- Excellent oral and written English communication skills; strong negotiation skills
- 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
- Must notify current manager if invited for an interview and be in current position for at least 18 months before applying to internal positions
