Statistician, Manufacturing Sciences & Tech

Emergent Biosolutions•Winnipeg, MB

11d•Hybrid

About The Position

The Statistician, Manufacturing Sciences & Technology (MS&T) is responsible for the statistical analysis, interpretation, and presentation of data generated from commercial manufacturing operations, including raw materials, microbiological programs, filling, and visual inspection. This role supports regulatory compliance through preparation of data for Annual Product Quality Reviews (APQRs) and other regulatory submissions. The position also manages and analyzes data generated from CDMO project work, contributing to the development of robust data processes, procedures, and continuous improvement initiatives. Working in a hybrid environment, the role is expected to further refine and expand existing statistical programs in collaboration with the MS&T team, and integrate filling and visual inspection data.

Requirements

Bachelor’s degree in Science, Engineering, Statistics or related field is strongly preferred; an equivalent level of education, skills, and experience will be considered.
5+ years of professional experience and a strong background in statistical analysis, preferably within the pharmaceutical industry
Experience using Excel, JMP and SAS platforms for analysis of data sets
Knowledge of cGMP with expertise in manufacturing processes and design, and Microsoft Office Suite of Products.

Nice To Haves

Experience with statistical process control would be an asset
Proficiency in Power BI considered an asset

Responsibilities

Prepare, analyze, and trend data from commercial manufacturing batches, raw materials, filling, and visual inspection routine process monitoring and decision-making.
Develop datasets, analyses, tabulations, graphical summaries, and listings to support internal reviews and regulatory requirements, including APQRs.
Support regularly scheduled data review meetings by preparing clear, accurate, and meaningful data presentations for cross-functional teams.
Support manufacturing operations by providing technical expertise, statistical interpretation, and insight into process performance and variability.
Collaborate with site stakeholders to support data analysis required for investigations, CAPAs, process validations, and other studies as needed.
Contribute to the development, refinement, and implementation of statistical programming SOPs, standards, and best practices.
Support project teams during technology transfer activities, ensuring data integrity and effective statistical support across project stages.
Work collaboratively with all departments and cross-functional teams to meet project deliverables and timelines.
Compiling department metrics.
Provide leadership during brainstorming and data review sessions, guiding discussions to ensure comprehensive evaluation of relevant data.