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Position: Senior Statistician
Institution: PSI CRO
Location: United States
Duties: Leading all biostatistics activities related to clinical trials as responsible project statistician; Development and review of statistical sections of protocols, including sample size calculations; Development of statistical analysis plans; Development and documentation of analysis database structures (i.e. SAS analysis dataset structures); Development of SAS program requirements and specifications; SAS programming and program validation
Requirements: MSc in Statistics or equivalent; At least 5 years of industry experience in clinical research; At least 5 years of industry experience in biostatistics; At least 5 years of experience in SAS programming; Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research; Very Good knowledge and understanding of the SAS programming language
   
Text: Senior StatisticianRemote, Remote, United StatesFull-timeCompany DescriptionWe’re over 1700 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for. Job DescriptionPosition Overview: Reporting 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! US Remote PositionThe scope of responsibilities will includePrimary responibilitiesLeading all biostatistics activities related to clinical trials as responsible project statisticianDevelopment 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 dataset 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 Statistics Corporate/Departmental AssignmentsParticipation in bid defense meetingsParticipation in 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 EducationMSc in Statistics or equivalentExperienceAt least 5 years of industry experience in clinical researchAt least 5 years of industry experience in biostatisticsAt least 5 years of experience in 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)SkillsExcellent presentation and communication skillsAdvanced knowledge of SAS softwareGood knowledge of MS office softwareAdvanced knowledge of CDISC ADaM IG 1.0 or later, define1-0-0.xml and define2-0-0.xml specificationsKnowledge of CDISC SDTM IG 3.1.3 or later and nQuery Advisor software is a plusAdditional InformationAll your information will be kept confidential according to EEO guidelines.Videos To WatchI'm interestedPrivacy PolicyI'm interestedRefer a friendshare this jobPowered by (Data Processor)Privacy Policy and Terms of UseShare to WeChat×Copy the link and open WeChat to share.Copy to clipboardOpen WeChatShare to WeChat×Use Scan QR Code in WeChat and click ··· to share.
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