Are you ready to apply your deep understanding of biostatistical methods in a company that follows science and turns ideas into life-changing medicines? If so, we invite you to join AstraZeneca as a Director of Biostatistics and Data Science (Biopharmaceuticals) in our Global Technical Operations Organization. In the Biologics Global Technical Operations (GTO), we work closely with AstraZeneca's manufacturing network of internal sites and external manufacturing partners (CMOs), our colleagues in R&D, Quality, Regulatory, Supply Chain, and Commercial to provide technical leadership to ensure delivery of quality products to our patients and support our product pipeline.
This is a key role within our organization, providing expert statistical and data analytical expertise. You'll be working under the guidance of the Digital Transformation Lead, integrating biostatistics within the organization to deliver innovative solutions and support strategic business transformation in the biopharmaceutical industry.
What you will do:
- Lead the application of biostatistical models to extract actionable insights and drive strategies and tactics.
- Develop appropriate statistical strategies and tools required to support analytical method assessments along with supporting test method validation and transfers.
- Provide support for regulatory file authoring, review, license renewals, and response to questions
- Influence end-to-end delivery of biostatistical insights, from framing the business question to designing the solution, and delivering recommendations.
- Foster collaboration and ensure seamless integration of biostatistical initiatives across the organization's infrastructure.
- Champion innovation and facilitate the adoption of new capabilities at scale.
Minimum Qualifications:
- Bachelor's degree with 15 years of experience in pharmaceutical or biotech industry
- Technical Skills: Deep understanding of biostatistical methods including mixed models, multivariate methods, categorical data analysis, mixed effects models, linear & nonlinear modeling, sampling plans, process controls, etc.
- High-level expertise with statistical software (R, SAS required; MatLab, Python, JM highly desirable)
- Track record of successful project leadership and delivery within a matrix organization.
- Excellent communication skills and relationship-building with customers.
- Domain Knowledge: Understanding of life sciences, preferably in a pharmaceutical environment with subject matter knowledge of bioproduct CMC development.
Preferred Qualifications:
- Bachelors, Master's, or Ph.D. in statistics, or a similar field with elements of statistics.
- Database programming (SQL, Oracle), VBA, .NET, and AWS SageMaker knowledge is desirable.
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we are driven by the desire to push the boundaries of science and deliver life-changing medicines. We are at an exciting time of new products and launches. Our Supply Chain team constantly strives for better, innovating, and evolving. We foster an encouraging, positive environment where ideas are welcomed and rewarded. We are a diverse team of experts connected across the globe, interpreting the science and connecting it with the business need to apply manufacturing excellence. If you enjoy working on complex activities and want to make a big impact, this is the place for you.
Ready to embrace constant challenges and work at the cutting edge? Join us! Together we can push the boundaries of science and deliver life-changing medicines
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 authorization and employment eligibility verification requirements.
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