Manufacturing Principal Statistician
Women In Bio - Rockville, MD
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OverviewWe have an exciting opportunity for a statistician to join our Digital and Data Science group, dedicated to supporting the launch of medicinal products to market and their subsequent product lifecycle within manufacturing. We are looking for an experienced manufacturing statistician to provide statistical support to Global Supply Chain operations at locations across the globe. In this role you will have the opportunity to collaborate with scientific colleagues in multidisciplinary teams in order to embed statistical thinking within projects whilst designing experiments and analysing data. This is an exciting opportunity to use your applied statistical skills to lead statistics capability build across a number manufacturing sites, providing ample opportunity to coach key individuals to acquire the skills needed for data driven decision making. Our team is part of global MSAT/'s Digital and Data Science organisation - a group of statisticians, data scientists, informatics and digital transformation experts with the mission to ensure data driven decision making is core to global MSAT/'s day to day activities.We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.Closing Date for Applications - 24th September 2025 (COB). This role is with GlaxoSmithKline (GSK). Please tailor your application materials to describe how you meet the competencies for this role, as outlined in the job requirements above. The information provided in your cover letter and CV will be used to assess your application.ResponsibilitiesLead high-quality statistical analysis and reporting in accordance with regulatory and internal guidance. Applications include planning and evaluation of experiments, sample size calculation, process and method validation, assay or process transfers, assay or process trending and root cause analysis investigations.Use a wide range of statistical methodologies including statistical process control, equivalence testing, linear modelling, design of experiments, acceptance sampling, multivariate methods and modelling using frequentist and Bayesian approaches.Act as an essential partner within international cross-functional project teams by providing critical statistical support to root cause investigations. Provide statistical expertise to the team and help interpret outputs to champion data driven decisions aligned to GSK values.Collaborate with R&D colleagues on new products to ensure smooth knowledge transfer and enable the launch of new products to market.Ensure integrity of statistical evaluation with appropriate methodologies and traceability/reproducibility.Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK SOPs, Ph.Eur., ICH/FDA guidelines).Monitor and assess new developments, industry trends, and regulatory expectations; standardise and refine statistics to apply state-of-the-art methodologies.Coach, mentor and train non-statisticians on statistical methodologies and data evaluation tools; train less experienced associates within the group and the organisation.Participate with the global statistical community of GSK to develop, align and standardise data evaluation methods, methodologies and conventions.QualificationsBasic Qualifications & SkillsMasters degree in statistics or biostatistics, or Bachelors degree in statistics/biostatistics with significant relevant experienceExperience in statistical consulting, working with non-statistical colleagues to devise practical statistical solutions, ideally within a pharmaceutical manufacturing settingKnowledge of statistical methodology in areas including statistical process control, acceptance sampling, DOE, linear regression, ANOVA, MSA, variance components analysis, equivalence analysis, tolerance intervals, mixed models, Monte Carlo simulation, Bayesian methods, and high-dimensional data analysis (MVA)Experience in statistical software (e.g. Statistica or JMP) including at least one programming language (e.g. R)Preferred Qualifications & SkillsPhD in statistics, biostatistics, or closely related fieldExcellent oral and written English communication skillsKnowledge of core API and drug product tests, unit operations and product control strategies across multiple dose formsAbility to communicate complex information clearly at different levelsAbility to independently manage workload and stakeholder communicationsImportant noticesGSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, pregnancy, gender identity, sexual orientation, parental status, national origin, age, disability, genetic information, military service or any basis prohibited under law. Our agile working culture and flexible opportunities are available where possible. For adjustments in the recruitment process contact or 0808 234 4391. If your enquiry does not relate to adjustments, please refer to the UK Recruitment FAQ. (Different links have been omitted for clarity.)Please note about employment businesses/agencies: GSK does not accept referrals from employment businesses/agencies without prior written authorization. Prices and commissions are not applicable to direct applications. #J-18808-Ljbffr
Created: 2025-09-27