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CompanyPhastar is a multiple award-winning integral biometric Contract Research Organization (CRO) accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.Why PhastarAccredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company‑wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment. As part of our ESG initiatives, we plant a tree in honour of every new employee.The RoleWe are seeking an experienced Statistician to join our FSP team to support a global pharmaceutical client, at either Senior or Principal level. The role is bright, adaptable and requires excellent communication and relationship building skills. The successful candidate will focus on GI or Oncology studies. The position is full‑time and fully remote (office/hybrid options available depending on location).ResponsibilitiesProgram and validate complex primary efficacy datasetsProgram and validate complex summary tables, listings and figures,



and program statistical analysis tables according to the SAPLiaise with clients to propose alternatives or additional analyses if neededDevelop and validate macros for statistical analyses and figuresPerform stage 3 QCAdvise on complex analyses and endpoints; ensure consistency across clinical trial programmesCreate, validate and QC efficacy dataset specifications for single studies, ISS/ISEs, etc.Write ISS/ISE SAPs, DSMB SAPs and ChartersWrite project‑level or therapeutic area‑level documentationPerform QC of SAP text and develop standard SAP text and templates for company useReview new standards and project‑level shells to ensure consistency across programmesWrite the statistical section of protocols for any studyProvide statistical consultancy at study design stage or during programme developmentConduct independent critical protocol reviewConsult with clinical scientists on best approaches for sample size calculation and executionPerform QC of sample size calculationsPerform complex simulationsCreate and QC complex randomisation schemesAct as unblinded DSMB statistician,



liaising with committee membersDistribute and communicate interim analysis results to stakeholdersAttend meetings as the independent statistician on the DSMB committeeCoordinate and lead clinical interpretation meetingsComplete clinical trial transparency forms and contribute to regulatory documentationSenior review of CSRArchive study documentation following SOPsPrioritise quality in all activities, following PHASTAR checklist principlesCreate, review and update processes and SOPs, identifying areas requiring new processesQualificationsPhD or MSc in Biostatistics/Statistics or a closely related fieldExperience in the pharmaceutical industry with awareness of clinical trial issues, design and implementationSolid statistical knowledge and capability in statistical analysis (e.g., binary and continuous data analysis, missing data handling)Experience in novel study design, Bayesian statistics or complex statistical analysis/modeling/simulations is a plusExperience writing SAPs and protocolsCritical thinkerPrevious experience as a Lead StatisticianProficient in SASAbility to work independently and collaboratively in a fast‑paced environmentEqual OpportunitiesPhastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnicity or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion or belief.#J-18808-Ljbffr

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📌 Principal Statistician (México)
🏢 PHASTAR
📍 México