RESPONSIBILITIES Provide statistical input for protocol development, study design, and CRF development by actively contributing to study design considerations in internal and client meetings, and providing and discussing sample size scenariosPerform sample size calculations and write statistical methodology sections for inclusion in study protocolsOversee production and quality control of randomization schedules, statistical analysis plans, statistical reports, statistical sections of integrated clinical reports and other process supporting documentsDesign statistical analysis plans and table shells in accordance with study protocols or for integrated efficacy and safety summaries for New Drug Application (NDA) submissionsDesign analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicableDevelop SAS programs to produce and/or QC statistical tables/figures/data listingsPerform mapping from raw datasets to CDISC SDTM datasetsProduce and perform quality control of define.pdf, define.xml and annotated case report forms for SDTM submissionDevelop SAS programs to produce and validate analysis datasets in CDISC ADaM or other formats specified by the sponsor and CDISC SDTM datasets from raw dataReview and/or write the statistical and results sections of clinical study reportsReview and/or assist in writing publicationsReview case report forms and data validation guidelines to ensure quality and integrity of study data collectionManage multiple projectsProvide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC reviewUnderstand regulatory requirements related to the specific therapeutic areas and the implications for statistical methodology and analysisSupport proposal development and attend bid defense meetingsReview Request for Proposal (RFP) and Scope of Work (SOW) documentsUnderstand the SOW, budget and task assumptions, and track work completed versus budgeted tasksManage project budget and forecast resources needed for studiesAdditional responsibilities as assigned by supervisor/managerEDUCATION Master's degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline requiredPhD degree in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferredEXPERIENCE Minimum of 5 years of experience in statistical analysis of clinical trials data orMinimum of 3 years of experience in statistical analysis of clinical trials data if relevant PhD degree has been obtainedSKILLS Experience with general linear models, mixed models, survival analysis, categorical data analysis and non-parametric methodsProficiency in SAS statistical programmingKnowledge of other statistical and data management software packages is a plusStrong written and oral communication skillsKnowledge and experience with CDISC data standards and modelsStrong project management and mentoring/leadership skillsIn-depth knowledge of applicable clinical research regulatory requirements; e.g., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesAbility to effectively manage multiple tasks and projectsAbility to clearly describe statistical techniques and interpret results