Principal Biostatistician

Prometrika Job OpportunityPrometrika is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes.ResponsibilitiesHaving wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining resultsProvide 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 dataMaintains expertise in state-of-the-art statistical analysesReview 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 reviewProvide training and guidance to junior level and new staffUnderstand 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/managerEducationMS in Biostatistics, Mathematics, Statistics, Public Health or related discipline requiredPhD in Biostatistics, Mathematics, Statistics, Public Health or related discipline preferredExperienceKnowledge of SAS statistical computing package is a mustKnowledge of other database management and statistical software packages is a plus10+ years of experience in statistical analysis of clinical trials dataSkillsExperience 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 resultsIncumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. Prometrika considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate's work experience, education/training background and parity with current employees in the same or similar positions.