Principal Statistician

You 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: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 BiostatisticsLiaise 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 levelQualifications: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 understanding of pharmacokinetics principles concepts methods and standards used in clinical research including the conduct NCL and population PK analysisExpert knowledge and understanding of Phoenix WinNonlin and NLMEExpert knowledge and understanding of relevant regulations and guidelines (e.g. FDA EMA ICH)Ability to apply a range of 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 skillsPlease submit your CV in English.Additional Information:Our mission is to be the best CRO in the world as measured by our employees clients sites and vendors.Our recruitment process is easy and straightforward and well be there with you every step of the way.Remote Work: YesEmployment Type: Full-timeKey Skills:SpssRRegression AnalysisStataSurvival AnalysisClinical TrialsStatistical SoftwareData MiningSASStatisticsData Analysis SkillsStatistical AnalysisExperience: yearsVacancy: 1#J-*****-Ljbffr