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Associate Principal Statistician

Macclesfield, Cheshire, United Kingdom, £ £ - Annual Annual, Permanent


*Associate Principal Statistician*
*9 Month Secondment / Fixed Term Contract*

*Location: Macclesfield UK, Sodertalje/Gothenburg Sweden*
*Competitive Salary & Benefits*
*Date Posted: 12.05.22*

*Build a long-term career by unlocking opportunities for lifelong learning*
Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities! We never stand still so you'll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment.

We have an exciting opportunity for an *Associate Principal Statistician* to strengthen our team! In this role you will work within *Technical Operations, Science and Innovation (TOSI)*, a key function of our Pharmaceutical Technology & Development (PT&D) organisation. The PT&D Organisation is responsible for drug product design, development and technical support for drug substance and products throughout the lifecycle.

TOSI is a multi-skilled Global organisation based in 13 locations in 7 countries who provide the authoritative technical support for AstraZeneca commercial small molecule drug products, product robustness, manufacturing technology strategy and Packaging Development & Technology.

Underpinning the excellent technical support that drives robust product supply are technical processes & strategies around knowledge management, manufacturability, technical validation approaches, problem solving in alignment with the delivery of the technical inputs needed for fulfilling the Global Product Supply Strategy. We work closely with many technical functions across Operations providing the ability to drive science and build capability within our organisation and our ways of working.

In Operations, we have a big ambition - to deliver more medicines to patients, quicker and more affordably. Now, more than ever, we're progressing. Using leading-edge science and digital technologies, we're driving automation and efficiency. Our vision of the 'Smart Factory' showcases us at our best. Disciplined thinkers and doers, we thrive in our often intense and ambiguous environment, seeking out new challenges and working towards new solutions. A place where anyone is supported to step up and lead, and everyone has the freedom to take ownership and drive outcomes forward.

*What you'll do*

In this role you will assist in expanding the supply of medicines to existing and new markets through the provision of statistical support to formulation and analytical technology transfers, including process and method establishment, process validation, process capability assessments and equivalence testing. Your contribution will ensure the continuous supply of medicines through advising on approaches and providing statistical support to the monitoring and analysis of quality data from manufacturing and testing processes to drive improvement of product robustness.

In addition you will;

* Support PT&D on market in driving the improvement of process and product robustness, ensuring continued product quality through the provision of statistical support to assist in the development and validation of assays for analysis of product quality attributes

* Work closely with process experts in resolutions of issues, by providing support through the determination of the data and analyses required to understand relationships and root causes

* Be involved in developing training materials and running statistical training sessions for non-statisticians

*Essential requirements*

* BSc with a significant statistical/mathematical component or equivalent experience

* Good presentation skills and the ability to deliver complicated statistical analysis to customers in a clear and understandable way, enabling further decision making processes

* Active listening skills, with the ability to scope the problem statement and to understand pain points of customers

* Evidence of excellent communication skills and relationship building with customers

* Experience in support of GMP manufacturing and testing environments e.g. Clinical or commercial batch production, or experience in support of drug product development activities

* User of at least one statistical package e.g. Minitab, JMP, SAS, R

* Understanding and practical application of descriptive statistics, statistical distributions, sampling strategies and sample size determination, equivalence and significance tests including analysis of variance and covariance techniques

* Application of Statistical Process Control e.g. trending, capability analysis for manufacturing data

* Application of DOE techniques

* Application of exploratory data analysis and regression/correlation techniques for exploring relationships within manufacturing/scientific datasets

* Production of appropriate graphs and figures for highlighting features and trends within manufacturing/scientific datasets

* Preparation of technical reports describing data analysis including the appropriate use of tables and visualisations

*Desirable Skills*

* MSc Statistics

* Knowledge in pharmaceutics/chemical engineering, through academic training or hands-on experience

* 6 Sigma green/black belt or equivalent experience

* Experience in support of regulatory interactions and responses

* Strong ability to work and handle multiple tasks at the same time

* Enthusiasm in helping customers to resolve problems and providing proactive suggestions in preventing similar issues recurring

*Be empowered to be innovative and creative where difference is valued*
Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.

*So what's next?*

Please apply with your CV and Cover Letter before the close date of 26th May 2022.

*Close Date:* 26.05.22

*Where can I find out more?*
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Job Details

Thu, 12 May 2022 16:08:00 EST
Not Specified
Macclesfield, Cheshire, United Kingdom
£ £ - Annual Annual