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 2,000+ 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 DescriptionReporting to the Director of Biostatistics, the Senior 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!Primary Responsibilities : Leading all biostatistics activities related to clinical trials as responsible project statisticianCommunication line for project teams, clients and vendors on statistical questionsDevelopment and review of statistical sections of protocols, including sample size calculationsDevelopment of statistical analysis plansDevelopment and documentation of analysis database structures (i.
e. SAS analysis data set structures)Development of SAS program requirements and specificationsSAS programming and program validationReview and QC of statistical deliverables (tables, listings, figures, etc.
Performing statistical analysis and reporting resultsProviding consultation on experimental design, statistical methods and approaches for the purpose of assessing safety and efficacy of drug productsLiaison with DM on statistical questions related to data issues, including coordination of data transfers from DM to StatisticsCorporate / Departmental AssignmentsParticipation in bid defense meetings and kick-off meetingsCommunication line for project teams, including statisticians and SAS ProgrammersCommunication line for customer on statistical questionsCommunication line for vendors on statistical questionsTrainingConduct of project-specific training of statisticians and SAS programmersCoaching and training of statisticians (non-project-related)Preparation and delivery of presentations at investigators' meetingsQuality AssurancePreparation for and attendance at internal and third-party study audits pertinent to StatisticsPreparation of the answers to the internal / external audits findings / recommendations, and follow-up on and resolution of audit findingsParticipation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department QualificationsMinimum Education : MSc in Statistics or equivalentExperience : Strong industry experience in clinical research, biostatistics and SAS programmingExpert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical researchVery good knowledge and understanding of the SAS programming languageStrong 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 informationStrong ability to consult with clinical investigators, interpret research requirements, and determine statistical analysis strategiesStrong ability to represent biostatistics in bid defensesStrong knowledge of relevant regulations and guidelines (e.
g. FDA, EMA, ICH)Skills : Excellent presentation and communication skillsAdvanced knowledge of SAS softwareGood knowledge of MS office softwareAdvanced knowledge of CDISC ADaM IG 1.
0 or later, define 1-0-0.xml and define 2-0-0.xml specificationsKnowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plusAdditional 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.SummaryType : Full-timeFunction : Research