AstraZeneca Pharmaceuticals LP Principal QA Statistician in West Chester, Ohio

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

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.

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%).

Essential Requirements:

  • Masters of Science Degree in Statistics

  • 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 Requirements:

  • 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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.