PCompany DescriptionpWe 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. /pJob DescriptionpYou 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. /ppstrongIn this role, you will: /strong /pulliAct as a communication line for project teams, clients, vendors and internal team on statistical questions /liliConduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis /liliDevelop and review study protocols, statistical analysis plans, analysis dataset specifications according to CDISC ADaM standard and other project-specific documents /liliReview statistical deliverables such as tables, figures, listings and analysis datasets /liliConduct departmental induction course and project-specific training for statisticians and SAS programmers /liliPrepare for and attend internal and external study audits pertinent to Statistics /liliParticipate in preparation of internal/external audits follow up /liliProvide input to standard operating procedures and other Quality Systems Documents (QSDs) pertinent to activities of Biostatistics /liliLiaise with DM on statistical questions related to data issues /liliParticipate in bid defense and in kick-off meetings /liliLead teams of SAS programmers and/or statisticians on the project level /li /ulQualificationsulliMSc in Statistics or equivalent /liliFull working proficiency in English /liliExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research /liliExpert knowledge and understanding of the SAS programming /liliExpert knowledge and understanding of CDISC ADaM standard /liliExpert knowledge and understanding of pharmacokinetics principles, concepts, methods and standards used in clinical research, including the conduct NCL and population PK analysis /liliExpert knowledge and understanding of Phoenix WinNonlin and NLME /liliExpert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) /liliAbility to apply a range of advanced statistical techniques in support of clinical research studies and to analyze, interpret, and draw conclusions from complex statistical information /liliAbility to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategies /liliStrong presentation and communication skills /li /ulpstrongPlease submit your CV in English. /strong /pAdditional InformationpOur 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. /p /p #J-18808-Ljbffr