PRINCIPAL & SENIOR STATISTICIAN OPPORTUNTIES
At Amgen, our mission—to serve patients—drives all that we do. This sense of shared purpose has allowed us to become one of the world’s leading biotechnology companies as we continue to launch new medicines at unprecedented rates and reach millions of patients worldwide.
The invaluable contributions of our talented employees help us develop vital and innovative medicines and we are looking for two talented individuals to join our Global Biostatistical Science team:
Principal Statistician - Link to role https://bit.ly/2XaFnYj
As the Principal Statistician, you will influence evidence generation strategies and study design, identifying opportunities for innovative methodology, whilst promoting statistical approaches both internally and externally ensuring strict adherence to all Amgen’s Policies, SOPs and other controlled documents. You will collaborate with Disease Area Leads and Global Statistical Leads to execute key projects, deliverables and operational tasks relating to biostatistical strategy, technical expertise and study reporting.
Responsibilities:
* Contribute to developing evidence generation strategies and product strategy plans
* Understand, promote and communicate innovative statistical methodologies, trial design, data analysis to clinical and other cross-functional experts
* Provide statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File (SDF) specifications, other key-study related documentation, TFL outputs, summaries of results, Clinical Study Reports (CSRs), clinical publications, and other communications involving disseminating results
* Completing statistical analysis of individual studies/projects
* Working in a team of statisticians, including members from external suppliers
* Publishing research in scientific journals and books, and giving presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
* Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
* Provide statistical consultancy, training and advice within Global Biostatistical Sciences and within Amgen
* Being familiar with statistical policy and strategy at Amgen and assisting in the development and review of Amgen Policies, SOPs and other controlled documents
* Assisting with study and systems audits conducted by Amgen and external bodies
* Serving as a team member of change / process improvement initiatives
Senior Statistician – Link to role https://bit.ly/2NbFCh7
As the Senior Statistician, you will influence study design and identify opportunities for innovative methodology, whilst promoting statistical approaches both internally and externally. You will ensure strict adherence to all Amgen’s Policies, SOPs and other controlled documents and you will lead multiple clinical studies and projects.
Responsibilities:
* Providing statistical contributions, statistical review and quality control of Key Design Elements (KDE) protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Figure (TLF) shells, Submission Data File (SDF) specifications, other key-study related documentation, TFL outputs, summaries of results, Clinical Study Reports (CSRs), clinical publications, and other communications involving disseminating results
* Completing statistical analysis of individual studies/projects
* Working in a team of statisticians, including members from external suppliers
* Publishing research in scientific journals and books, and give presentations on statistical methodology in the biopharmaceutical setting at external scientific meetings (biopharmaceutical industry and academic meetings)
* Being familiar with statistical policy and strategy at Amgen
* Staying abreast of latest developments in the field of statistics in drug development and contribute to scientific advances in the field
* Communicating the role of the Global Biostatistical Sciences department, and may contribute to statistical training within Global Biostatistical Sciences and within Amgen
* Assisting in the review of Amgen Policies, SOPs and other controlled documents
* Assisting with study and systems audits conducted by Amgen and external bodies
* Serving as team member of change / process improvement initiatives
To apply click on the links above or for more information please get in touch with Amanda Edwards ([log in to unmask]<mailto:[log in to unmask]>)
Amgen Limited, a company incorporated in England with number 2354269. Registered office: 240 Cambridge Science Park, Milton Road, Cambridge CB4 0WD, UK The information contained in this e-mail transmission is confidential and may be legally privileged. If you are not the intended recipient, any use, dissemination, distribution, publication, or copying of the information contained in this e-mail is strictly prohibited. If you have received this e-mail in error, please immediately notify us by telephone at +44 (0)1223 420305 or by e-mail to the sender and delete the e-mail from your system. Thank you for your co-operation. Amgen accepts no responsibility for changes to or interception of this e-mail after it was sent or for any damage to the recipient's systems or data caused by this message or its attachments. Please also note that messages to or from Amgen may be monitored to ensure compliance with Amgen policies and standards and to protect our business
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