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Senior/Associate Principal Statistician - CMC Statistics

Cambridge, Cambridgeshire, United Kingdom, £ £ - Annual Annual, Permanent


*Senior/Associate Principal Statistician - CMC Statistics (Non-clinical)*
*Cambridge, UK or Gaithersburg, MD*
*Salary & Benefits Competitive*

*Make a more meaningful impact to patients\' lives around the globe*

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There\'s no better time to join our global, growing enterprise as we lead the way for healthcare and society.

The setup: An exciting bioscience hotspot, Cambridge is home to one of AstraZeneca\'s three strategic, global R&D Centres, alongside Gothenburg and Gaithersburg. Over 3,600 employees are based in Cambridge. Our offices are internationally renowned for attracting high performers, including several Nobel prize winners.

Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world\'s most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world.

*Typical Accountabilities*

* Acts as a regional technical expert supporting the delivery of statistical outputs within the area of statistics and provides statistical consultancy in support of biopharmaceutical development (cell culture, purification, analytical, stability, formulation, devices, etc.)
* Develops operational systems and research processes across area of responsibility to increase the effectiveness and efficiency of projects
* Acts as a source of knowledge in area of expertise, defining and communicating important initiatives across departments and functions
* Contributes to establishing and implementing policies, procedures and objectives for own work to ensure compliance with both internal and external regulations
* Leads the development of setting statistical standards or techniques in order that the quality, efficiency or effectiveness of projects are improved for overall Group efficiency
* Accountable for specialised research to enhance the effectiveness of Biostatistics contributions to worldwide submissions across a range of products
* Provides highly experienced strategic input, statistical expertise, and leadership to project teams in the design and interpretation of clinical studies and programmes of studies
* Applies expert statistical skills to support internal proposal development and external regulatory submissions
* Promotes good statistical practice and ensures adherence with relevant statistical protocols
* Areas of emphasis include, design and analysis of experiments, comparability, assay validation, specification setting and product stability

*Education, Qualifications, Skills and Experience*

* Advanced degree within field and/or professional certification

* Significant experience in statistics for CMC development of biological therapeutics (cell culture, purification, analytical, formulation, devices, etc.)
* Proficiency with statistical software, R and JMP required. MatLab, Python and SAS highly desirable.
* Must possess excellent interpersonal skills, especially when communicating statistical concepts to non-statisticians.
* Excellent written and verbal communication, business analysis, and consultancy skills
* Customer focus - dedicated to meeting the expectations and requirements of internal and external customers


* Publication history in the field
* Database programming (SQL, Oracle)
* VBA, .NET, AWS SageMaker knowledge also desirable.

At AstraZeneca we\'re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\'s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

*So, what\'s next?*
Complete your application before the below closing date.
This role is open from 01/09/2021 and welcome with your application no later than 29/09/2021

*Where can I find out more?*
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Job Details

Tue, 14 Sep 2021 11:07:00 EST
Not Specified
Cambridge, Cambridgeshire, United Kingdom
£ £ - Annual Annual