Job DescriptionYou will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers and data managers, including the role of biostatistics project lead.In this role, you will:
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Act as a communication line for project teams, clients, vendors and internal team on statistical questionsConduct statistical analysis for clinical trials including interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysisDevelop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documentsReview statistical deliverables such as tables, figures, listings and analysis datasetsConduct departmental induction course and project-specific training for statisticians and SAS programmersPrepare for and attend internal and external study audits pertinent to StatisticsParticipate in preparation of internal/external audits follow upProvide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics departmentLiaise with DM on statistical questions related to data issuesParticipate in bid defense and in kick-off meetingsLead teams of SAS programmers and/or statisticians on the project level
Qualifications
MSc in Statistics or equivalentFull working proficiency in EnglishExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical researchExpert knowledge and understanding of the SAS programmingExpert knowledge and understanding of CDISC ADaM standardExpert knowledge and xrdztoy understanding of adaptive designsExpert knowledge and understanding of sample size calculationExpert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH)Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical informationAbility to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategiesStrong presentation and communication skills
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