Scientist I, Analytical Development and Clinical Quality Control

We are seeking a highly motivated scientist with wet lab experience and biostatistics to support statistical needs across analytical method development and ensuring clinical consistency. This contractor position will collaborate closely with analytical scientists and groups responsible for clinical stability to ensure data-driven decisions robust method performance and regulatory. The ideal candidate will provide biostatistics support to groups in Analytical Development and Clinical Quality Control! They will use statistical analysis for method comparability assessments. They will model degradation kinetics and calculate degradation rates with appropriate regression models. They will develop data visualizations and statistical summaries for internal reports. Perform batch analysis and review results. This position may also support the planning execution and documentation of clinical stability activities as needed.

You will be responsible for:

• Partner directly with analytical development and clinical stability teams. Develop reporting and analytics solutions that support quality and timely delivery of data management reports and visualizations. These must meet SOP and study-specific data review plans.
• Directly supports knowledge development of others on data visualization and analysis tools that support assay performance and the accuracy/integrity of study data.
• Aligns with applicable SOPs and work practices. Draft and revise SOPs related to data management and analyses.
• Collaborate with key analytical development and clinical quality control team members to generate clear reproducible statistical reports and result interpretation that align with ICH guidelines and regulatory expectations. Serve as a technical resource to the study teams for data trending for assay performance data visualization and reporting tools.
• Serves as a lead for data management including providing scientific feedback on assay performance via data collection and trending.
• Reviews ELNs and verifies data in method development qualification/pre-validation reports.
• Positively contributes to improving the working environment and engaged in ongoing Alexion cultural improvement efforts.

You will need to have:

• Bachelors or masters degree in Statistics Biostatistics Applied Mathematics or related field. A minimum of 2-5 years proven experience in a pharmaceutical biotech or scientific R&D environment with an emphasis on building reporting and analytics solutions.
• Solid understanding of statistical techniques including ANOVA regression multivariate analysis DoE and time-series/trending analysis.
• Proficiency with statistical software (e.g. JMP SAS R Minitab Oracle PL/SQL relational database design and database programming skills)
• Proficiency with data orchestration and integration is strongly preferred.
• High level of proficiency in Microsoft Office Suite of tools (Outlook Word Excel etc.)
• GMP experience in analytical testing and familiarization with testing assays is preferred.
• Understanding of drug development process batch release testing and data operations required for the reporting in variety of format is preferred (e.g. data review date trending for assay performance study reports regulatory submissions etc.)
• The duties of this role are sometimes conducted in a lab environment. As is typical of a lab-based role employees must be able with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological infectious and hazardous materials; gown/de-gown PPE; use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours

When we put unexpected teams in the same room we spark bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility.

Join us in our unique and ambitious world.

Why AstraZeneca:

Here courage curiosity and collaboration fuel a relentless focus on transforming cancer outcomes powered by a pipeline that fuses cutting-edge science with advanced technology. You will work in an environment where unexpected teams come together to spark bold ideas backed by meaningful investment and a clear path from discovery to impact. We value kindness alongside ambition and we empower leaders at every level to ask sharp questions take smart risks and turn data into decisions that help patients sooner.

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.