Biostatistical Programming Manager

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.

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.

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, 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

Basic Qualifications:

Doctorate degree
OR
Master's degree and 3 years Statistical Programming experience
OR
Bachelor's degree and 5 years Statistical Programming experience

OR

Associate's degree and 10 years Statistical Programming experience

OR

High school diploma and 12 years Statistical Programming experience

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

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