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Principal QA Statistician - Global Operations

Lieu Mount Vernon, Indiana, États-Unis Gaithersburg, Maryland, États-Unis Newark, Delaware, États-Unis Frederick, Maryland, États-Unis Wilmington, Delaware, États-Unis Job ID R-074106 Date de publication 02/12/2020
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Principal QA Statistician, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world – 20% of our global workforce. With 30 production facilities in 18 countries we’re focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that’s full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.

The Principal QA Statistician role is critical for solving and preventing critical business problems in the Americas Operations, and in providing strategic direction to AZ Operations in the area of Statistics application and capability.  The position requires an experienced statistician with a proven track record of applying statistical ideas for consulting and developing methods.  This role serves as a key contact to influence colleagues laterally and vertically (including senior leadership) to use statistical approaches to achieve results at either a project or functional level.

The statistician role is a strategic role and helps to align best practices of using statistical approaches cross-functionally.  Statisticians are expected to provide in depth technical knowledge and leadership in statistics and its application, especially in driving lean behavior, problem solving, preventative action, and continuous improvement.

This position could be located at various sites, Mt. Vernon, IN, Gaithersburg, MD, Frederick, MD, Wilmington, DE, Newark, DE, West Chester, OH etc.

Job Responsibilities: 

Major Activities and Responsibilities:

This position is responsible for the design, development and implementation of statistical methodologies in support of production sites in the Americas region (80%) and in support of global Operations activities as members of the Operations Statisticians Forum (10%), and for staying current with and influencing development of external positions in areas of statistics (10%).

Statistical Support / Analysis

  • Provide statistical evaluations for the Annual Product Reviews, and statistical evaluation and implementation of manufacturing process controls to support manufacturing sites in meeting their regulatory requirements
  • Provide support and training to manufacturing sites in implementation of key Operations initiatives (e.g., CPV)
  • Designs and analyzes efficient experiments to optimize use of resources to collect information for investigations, validations, and process improvements.
  • Designs and develops statistical applications for use by others within the site for ongoing monitoring and analysis of site data (e.g., Validation, in-process controls, IQ, OQ, and PQ studies of production processes, batch investigations). 
  • Executes ad-hoc evaluations of Quality Operations and R&D process data in support of new product introductions (technical transfer and launch of new molecular entities) to the sites.   This may include reassessment and confirmation of in-process controls and release specifications.
  • Leads projects in the improvement of internal work processes (continuous improvements / lean initiatives / preventative actions.)
  • Designs and executes ad hoc evaluations of packaging components (machinability) and performs a statistical evaluation of the data obtained from these evaluations.
  • Provides assistance in designing and statistically evaluating analytical and process validation studies, trouble-shooting, and data for NDA and international regulatory submissions.
  • Develops and implements sampling plans for all materials used and manufactured in US Operations: Purchased chemicals, purchased packaging components, in-process manufacturing and packaging, and finished products.
  • Serve as consultant / expert by providing statistical expertise and problem solving into key drug product/process functional and project related activities.
  • Propose innovative business focused statistical approaches, challenge the status quo, and promote approaches to improve robustness and quality of data driven decisions in the business.
  • Proactively determines where statistical practices can create efficiencies and effectiveness at the manufacturing sites.
  • Also serves as a technical resource to educate and share knowledge and though process about statistical analysis with colleagues and team members both laterally and vertically.

Global Operations Statisticians Forum

  • Partner with AZ statisticians globally for consistency of analyses and sharing of knowledge and techniques.
  • Provide strategic input into global Operations projects.
  • Develop statistical tools and training materials and provide training to AZ staff in support of global projects.

External Advocacy

  • Keep abreast of external developments in the industry
  • Interact with industry groups in writing and/or presenting papers

The incumbent is not necessarily performing all the Major Responsibilities of the role immediately.  The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs.  Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

Requirements:

Education:  

  • Masters of Science Degree in Statistics

Required: 

  • 5-10 years of statistical experience
  • Expert user of several statistical packages
  • A working knowledge in applying a wide range of statistical analyses to a pharmaceutical production/research environment
  • Knowledge and familiarity with cGMPs, compendia and regulatory standards and guidelines
  • Excellent written and oral communication skills
  • Experience in applying the concepts of:
    •  Statistical Quality Control
    • Statistical Process Control
    • Linear modeling
    • Experimental Design
    • Survey Sampling
    • Exploratory Data Analysis

Desirable:

  • PhD in Statistics with a Bachelors degree in Statistics, Engineering, Mathematics or one of the life sciences
  • 10-15 years of statistical experience
  • Pharmaceutical QA or research experience ideal

In addition to minimum technical requirements, ideally will have:

  • Experience in a Quality Assurance production environment
  • Involvement with Industry Statistical Working Groups
  • Ability to cascade knowledge through training and education on statistical approaches
  • Experience in applying the concepts of:
    • Statistical Quality Control
    • Linear and non-linear modeling
    • Experimental Design
    • Multivariate Analysis
    • Survey Sampling
    • Categorical Data Analysis
    • Exploratory Data Analysis

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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