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 Senior Principal Statistician in Frederick, MD, 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.
Main Duties and Responsibilities
The Senior Principal Statistician of Process Statistics within the Global Tech Operations department is responsible for providing statistical support across a broad range of technical areas, including analytical, process development, drug substance and drug product manufacturing monitoring, process/product/assay trending, and promoting applications of statistics in analytical and process development, validation and optimization. He/she is also responsible for providing direction and statistical oversight for the internal and external projects that GTO leads/supports.
Major Duties and Responsibilities:
- Provide statistical support for GTO projects, support acceptance criteria setting and data analysis for:
- Life-cycle management of specifications for commercial products
- Analytical method transfer, validation and optimization.
- Product, process, assay and stability trending
- Drug substance/product process study design
- Maintain models to summarize current level of process and product understanding
- Implement advanced data mining and monitoring tools to track process performance and product quality for commercial production across sites
- Apply statistical techniques to facilitate better decision making and improve business operation
- Collaborate with statisticians in other departments in improving and sharing statistical approaches
- Collaborate with colleagues from other divisions or departments to achieve corporate goals
- Lead or participate in establishing statistical SOP and guidelines
- Represent GTO on cross-project initiatives such as specification strategy, QbD and PAT
Minimum of 12 years with BS, 10 years with MS, and 5 years with Ph.D. Minimum of 3 years’ experience in process statistics in the manufacturing, preferably Biotech or Pharmaceutical industry.
- Demonstrated competency in managing multiple projects and processes
- Comprehensive knowledge of applied statistical principles and modeling in the design and analysis of non-clinical studies, process monitoring and control
- Familiar with pharmaceutical or biotechnological manufacturing process and regulations as well as the validation and technology transfer of analytical methods.
- Proficiency in statistical software such as JMP, SAS and R
- Apply advanced statistical principles, theories, and concepts to make life-cycle changes to manufacturing processes as well as analytical specifications
- Contribute to the development of novel statistical methods to resolve problems during manufacturing operations as well as analytical testing
- Excellent interpersonal skills and effective oral and written communication skills
- Excellent organizational skills and successful management experience
- Experience in departmental SOP and process development improvements
- Comprehensive knowledge of regulatory guidelines
- Experience in interactions with regulatory agencies and submissions
- Experience in technology transfer (both process and analytical), process monitoring and improvement
Requires juggling multiple projects with varying priorities. Require ability to recognize issues that may critically affect statistical analyses and to relay that information to customers and appropriate level of management. Require providing novel solutions to complex problems. Requires working closely with multiple globally based groups to provide technical as well as statistics support and requires strong communication skills to influence outcomes.
Work under limited consultative direction toward predetermined long range goals and objectives.
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.