Company DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need DescriptionSenior Statistician is an integral part of our team here at PSI. If you have experience in clinical research, understand SAS programming principles and concepts, and have a good knowledge of statistical methods, apply today!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 SAS analysis data set structures)Develop SAS program requirements and specificationsSAS programming and program validationReview and QC of statistical deliverables (tables, listings, figures, 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 findingsParticipate in the development of guidelines, proceduresQualificationsMSc in Statistics or equivalentExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical researchKnowledge and understanding of the SAS programming language; advanced knowledge of SAS softwareAbility 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 knowledge of CDISC ADaM IG or later, define and define specifications Knowledge of relevant regulations and guidelines FDA, EMA, ICH)Presentation and communication skillsAdditional InformationMake the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as submit your in English.