If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Principal Statistician in Boulder, CO, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
~bsp Main Duties and Responsibilities
You will function independently as a principal statistician for multiple projects that provide support primarily to the Quality organization but you may assist other organizations at the Boulder Manufacturing Center. This includes providing consultation about collection and analysis of data obtained for method transfer, product commercialization and regulatory filing, facility qualification activities, process data, and deviations and investigations. You will be responsible for authoring protocols, plans, and reports summarizing statistical analyses and successfully communicating verbally and in writing to non-statistical audiences. In addition, you will be responsible for setting rational and defendable trending limits, acceptance criteria, and process tolerances in support of GMP operations. You will participate in and provide evaluation of data for deviations and investigations, root cause analyses, and regulatory technical writing (BLA/IND/APR). You will work cross-functionally with groups outside Quality as well as with peers throughout the network to establish consistent statistical approaches. You may be required to interact with regulatory agencies verbally and in writing.
Primary activities include assessing and analyzing data sets in support of GMP operations. Own and author technical reports detailing statistical analyses. Provide written and verbal communications to non-statistical audiences. Assist in investigations and root cause analysis. Contribute to regulatory filings and annual product review.
- MS or PhD in statistics or other related field with rigorous statistical training
- Eight plus years of related experience applying statistical analyses.Minimum of four years of experience in GxP environment.May reduce experience by two years with PhD.
- Experience with method transfer in commercial manufacturing
- Broad understanding of application of statistical methods to pharmaceutical problems
- Ability to apply statistical principles and techniques to provide solutions to a wide range of problems at various stages of drug product life cycle management.
- Experience in regulatory interactions
- Excellent statistical programming skills and experience with study design and analysis software such as JMP and SASS
- Strong technical writing ability
- Effective oral and written communication and interpersonal skills
- Ability to communicate within and outside the organization.
- Ability to independently represent the organization in providing solutions to difficult technical issues associated with specific projects and applications.
- Works under general direction and is able to find solutions independently.Present solutions for approval and able to implement.
- Ability to successfully work with ambiguity.
- Ability to be flexible and adapt to changes in priority.
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.