Biostatistical Programming Mgr

at  Amgen

Job Description

BASIC QUALIFICATIONS:

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

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

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role you will ensure all statistical aspects pertaining to clinical activities meet required standards and are statistically accurate.
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)