Top 3 must haves:
Local candidate to Mounds View, MN needed.
SAS programming experience
Masters Degree is Statistics or Bio Statistics
Manager is open to less experience if they have a masters degree and SAS experience.
Member of Cardiac Rhythm and Heart Failure statistical team responsible for Statistical analysis using SAS and other tools across multiple trials.
Primary tasks include data analysis, programming of tables and listings within targeted timelines for interim and/or final report submission; support on-going needs for ad-hoc analysis.
ESSENTIAL FUNCTIONS: Perform statistical data analysis for clinical studies using SAS and other software such as Excel, R, etc.Generate Statistical Analysis Plans (SAP) working with the Clinical Project Manager and team for various types of clinical studies (Feasibility, Pre-Market, Post-Market) Assist in the protocol development for clinical studies to ensure that a valid sample size is chosen to adequately test the hypothesis and to ensure that proper statistical methods are employed. Will also present statistical results in graphs, tables, reports and manuscripts as needed at the time of interim analysis, abstract submissions and/or ad-hoc requests. This person will use statistical techniques to monitor data quality and perform ad-hoc analysis/ p-value calculations etc. on clinical study data as needed. Will provide review and input in Oracle Clinical study design as needed with respect to defining Data Extract Views, SAS names etc. May need to prepare and/or present for FDA panel review meetings. Interaction with upper management as well as principal investigators/clinicians may be required for data presentations and manuscript review. Interaction with vendors and outside Statisticians will be required at times. May have to work on legacy studies to run ad-hoc analysis and/or data pooling etc. Analyze data to meet clinical protocol requirements. Review protocol during development to provide inputs on statistical plan, sample size, interim analysis, and final analysis. Report results with highest integrity
DEPARTMENT SPECIFIC/NONESSENTIAL FUNCTIONS: Other duties as assigned with or without accommodation Expertise in statistics o Understand statistical concepts and techniques, such as design of experiments, analysis of variance, linear and nonlinear regression, non-parametric methods, data mining, sample size calculations, etc. Expertise in statistical software, preferably SAS to support regulatory studies o High efficiency in SAS programming and/or other statistical analysis tools Knowledge of Regulatory Requirements o Knowledge of relevant statistical regulatory guidance and standards (e.g., FDA, ICH and EMEA) Excellent organizational skills and attention to detail o Prioritize and effectively manage several projects simultaneously o Meet project deliverables and timelines from a statistical perspective o Work collaboratively within a multidisciplinary team Oral and Written Communication Skills o Competency in English both in oral and in written o Succinctly write statistical analysis documents, (e.g., analysis plans) o Competency in explaining the results of the statistical analysis to the clinical study team and other clients in verbal and writing o Ensuring that the results have been appropriately interpreted in the report
MINIMUM REQUIREMENTS: Education and Experience: Advanced degree (M.S. or Ph.D.) in Biostatistics, Statistics, Computer Science, or Mathematics. Relevant experience with data collection/statistics preferably for medical device and/or pharmaceutical clinical trials. Skills/Qualifications Other Skills: Competency in SAS programming and Statistical analysis methods/tools Ability to perform univariate and multivariate statistical analysis using models (linear and logistic regression) Ability to perform meta-analysis a plus (for literature review) Computer literacy in MS Word, Excel, PowerPoint, Access etc. Oracle Clinical system knowledge a plus Ability to prioritize and multitask Able to effectively communicate with Clinical, Data Management and Statisticians Excellent organizational skills and attention to detail. Ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents Ability to redact statistical report (including statistical results interpretation) Ability to work as a team and autonomy will be appreciated Competencies: Customer Focus Ethics and Values Functional/Technical Skills Priority Setting Problem Solving
WORKING CONDITIONS: Normal office conditions. Minimal travel may be required (?5%). 0-5 years experience
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