Scientist I, Analytical Development and Clinical Quality Control

Alexion•New Haven, CT

14h

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.

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)
Proficiency with data orchestration and integration is strongly preferred.
High level of proficiency in Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)

Nice To Haves

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. 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.