Biostatistical Programming Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Biostatistical Programming Manager

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)

• 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

• Advise FSP SLP on study-specific questions for specifications, documentation, and coding

• Lead/contribute to GSP continuous improvement initiatives

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is proficient with these qualifications.

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

• 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

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is po