Biostatistical Programming Manager – Technical Manager

Career Category

Clinical

Job Description

If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Biostatistical Programming Manager – Technical Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be oversee our Functional Services Provider (FSP) focusing on operational excellence and delivering projects on time to the levels of high quality and compliance. You will coordinate the implementation and quality of projects managed by FSP and ensure that projects are prioritized according to the product strategy.

Additional responsibilities:

• Responsible for projects managed by our FSP partners per Amgen Global Statistical Programming (GSP) Quality Oversight Plan (QOP)

• Ensure that FSP programming meets quality, compliance, timeline, and productivity expectations

• Align FSP assignments with Amgen Development priorities

• Responsible for FSP performance metrics development, data collection, and reporting and lead the GSP continuous improvement initiatives

Be part of our team

You would be joining the Global Statistical Programming team who serve patients by translating clinical study data into important summaries to support high-quality submissions.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:

• Bachelors degree or equivalent in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific subject

• Extensive SAS programming and reporting experience including SAS Base, Macro, STAT, Graph, and SQL, among others

• Detailed understanding of clinical trial processes in the biopharmaceutical industry, from data collection to analysis reporting

• Ability to lead programmers in successful completion of all study programming activities and provide mentorship on technical and process related questions

• Experience working in a globally dispersed team on Phase 1-4 clinical trials

• Experience creating SDTM and ADaM data sets, Tables, Figures and Listings

• Ability to define and implement an effective standardization strategy for a product following the latest CDISC SDTM, ADaM and define standards.

• Familiarity with other programming languages such as R and Python

• In-depth knowledge of SAS/Graph and STAT

• Regulatory submission experience

• Vendor and resource management experience

• Detailed understanding of data compliance checks such as Pinnacle 21

LOCATION Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

• Flexible work models, including remote work arrangements, where possible

Apply now

Objects in your future are closer than they appear. Join us.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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