.Posted on:15/05/2024Job type:PermanentSector:Pharmaceutical and HealthcareMissionThe Senior Statistician will be responsible of the design and statistics of clinical trials and clinical development projects. The Senior Statistician will partner with senior scientists in clinical (Global Development and Global Medical Affairs), safety, regulatory, market access and research on clinical development projects, pricing and reimbursement dossiers and publications.Tasks and ResponsibilitiesClinical Development:Member of clinical team, collaborating in preparation of Clinical Development Plans according to the Target Product ProfileRegarding Clinical Trials, he/she participates in the Synopsis and Protocol development, being accountable and author of statistical sections of protocols and other regulatory documents.Prepare the statistical analysis plan(s) (SAP) according to the study protocols, and also Table, Figures, and Listings (TFL) formats. Supervise programming activities relating to statistics.Accountable and authors of the Statistical Report from the study results, with active collaborate in the revision of the the Clinical Study Report.His/her contribution will be required with Health Authority & Ethics Committee Documents during the approval procedures, when asking about statistical methodology used in clinical trials, dossier submissions and interpretation of the results.Oversees the deliverables from Statistical & Programming CROs. Leads the generation of health authority submission datasets and associated documentation.Participates actively, when needed, in Health Authority meetings and Advisory Boards, Publications and other presentations.Collaborate with Market Access in preparing the Value Dossier Proposition to the HTA, maximizing the available date and using the appropriate methodology to defend the proposals.Statistical methodology:Investigate and apply new statistical methodologies to facilitate increasing quality and efficiency in clinical development.Analyse and evaluate new statistical software.Hold meetings with external advises and regulatory authorities when required, with the aim of updating and optimizing the statistical methodologies used and guaranteeing their correct application.Statistical activities performed by external companies (Contract Research Organization, CRO; Academic Organization, etc.):Ensure the delivery of the CRO activities contracted out. The deliverables should be according to predefine quality, timelines and cost. (Statistical sections of the protocol, SAP, statistical analyses and preparation of the statistical reports)Evaluation of Statistics CROs.Supervision of Programing activities.Collaborate with companies specialized in Market access activities and knowledge.Education, Experience and Skills:PhD in statistics or minimum of 8 years of relevant pharmaceutical industry experience working as statistician
