Principal Statistician (Pharmacokinetics)

Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.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: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 levelQualificationsMSc 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 skillsAdditional InformationOur 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 we’ll be there with you every step of the way. SummaryType: Full-timeFunction: OtherExperience level: Mid-Senior LevelIndustry: Pharmaceuticals