ppWe are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do.A dynamic, integral 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. /ph3Job Description /h3pbIn this role, you will: /b /pulliLead all biostatistics activities related to clinical trials as responsible project statistician /liliCommunicate with project teams, clients and vendors on statistical questions /liliDevelop and review statistical sections of protocols, including sample size calculations /liliDevelop statistical analysis plans /liliDevelop and document analysis database structures (i.e. SAS analysis data set structures) /liliDevelop SAS program requirements and specifications /liliSAS programming and program validation /liliReview and QC of statistical deliverables (tables, listings, figures, etc.) /liliPerform statistical analysis and report results /liliConsult on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug products /liliLiaise with DM on statistical questions related to data issues,



including coordination of data transfers from DM to Statistics /liliParticipate in bid defense meetings and kick-off meetings /liliTrain statisticians and SAS programmers /liliPrepare and deliver presentations at investigators' meetings /liliAddress audits findings/recommendations, and follow-up on and resolution of audit findings /li /ulh3Qualifications /h3ulliMSc in Statistics or equivalent /liliExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research /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 /liliExpert knowledge and understanding of the SAS programming /liliExpert knowledge and understanding of CDISC ADaM standard /liliKnowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH) /liliAbility to work in English /li /ulh3Additional Information /h3pOur 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. /ppBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy apply /p /p #J-18808-Ljbffr

📌 Senior Statistician (Madrid)
🏢 Psi Cro
📍 Madrid