Duration: 12 months to start

Job Description

• We are seeking a highly motivated and detail-oriented statistician to support statistical needs across analytical method development and clinical stability.
• This contractor position will collaborate closely with analytical scientists and clinical stability teams to ensure data-driven decisions, robust method performance and regulatory compliance.
• The ideal candidate will provide biostatistics support to other Analytical Development and Clinical Quality Control working groups using statistical analysis to support method comparability assessments, model degradation kinetics and calculate degradation rates using appropriate regression models, develop data visualizations and statistical summaries for internal reports and perform batch analysis and/or standards/results trending.
• This position may also support the planning, execution, and documentation of clinical stability activities, as needed. 

• Cross-functional collaboration: work closely with analytical development and clinical stability teams for to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per SOP and study specific data review plans
• Directly supports knowledge development of others on reporting and analytics tools that support assay performance and the accuracy/ integrity of study data
• Complies with applicable SOPs and work practices. Draft and revise SOPs related to data management and analyses
• Interface with key analytical development and clinical quality control stakeholders to generate clear, reproducible statitistical 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 on-going cultural improvement efforts

• Bachelor’s or Master’s degree in Statistics, Biostatistics, Applied Mathematics, or related field. A minimum of 2-5+ years relevant experience experience in a pharmaceutical, biotech, or scientific R&D environment with an emphasis on building reporting and analytics solutions.
• Strong knowledge 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)
• Excellent interpersonal skills and a strong ability to communicate effectively
• 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