We 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 current medicines to those who need them.Job DescriptionIn this role, you will:Lead all biostatistics activities related to clinical trials as responsible project statisticianCommunicate with project teams, clients and vendors on statistical questionsDevelop and review statistical sections of protocols, including sample size calculationsDevelop statistical analysis plansDevelop and document analysis database structures (i.E. SAS analysis data set structures)Develop SAS program requirements and specificationsSAS programming and program validationReview and QC of statistical deliverables (tables, listings, figures, etc.)Perform statistical analysis and report resultsConsult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug productsLiaise with DM on statistical questions related to data issues,



including coordination of data transfers from DM to StatisticsParticipate in bid defense meetings and kick-off meetingsTrain statisticians and SAS programmersPrepare and deliver presentations at investigators' meetingsAddress audits findings/recommendations, and follow-up on and resolution of audit findingsQualificationsMSc in Statistics or equivalentExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical researchAbility 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 strategiesExpert knowledge and understanding of the SAS programmingExpert knowledge and understanding of CDISC ADaM standardKnowledge of relevant regulations and guidelines (e.G. FDA, EMA, ICH)Ability to work in EnglishAdditional 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. #J-18808-Ljbffr

📌 Senior Statistician (Toronto)
🏢 PSI CRO
📍 Toronto