Scientist I, Analytical Development and Clinical Quality Control

AstraZeneca•New Haven, CT

20h•Onsite

About The Position

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: Bachelor’s or master’s 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 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 four 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. 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. Date Posted 23-Feb-2026 Closing Date 01-Mar-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Requirements

Bachelor’s or master’s 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)
High level of proficiency in Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Nice To Haves

Proficiency with data orchestration and integration is strongly preferred.
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.)

Responsibilities

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.
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.