Biostatistical Programming Manager – Technical Manager
Apply remote type Flex Commuter / Hybrid locations United Kingdom - Uxbridge United Kingdom - Remote time type Full time posted on Posted Yesterday job requisition id R-196118
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 reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
What you will do
Let’s do this. Let’s change the world. In this vital role you will 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.
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 in Uxbridge next generation workspace. Candidates who do not live within a commutable distance have the opportunity to work fully remotely within the United Kingdom.
What you can expect of us
* 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.
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.
About Us
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing 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.
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