Serves as project statistician for basic and advanced biostatistical and psychometric analysis activities, from planning to implementation and delivery of results. Works closely with principal investigators, project managers, and statistical programmers in the response to proposals, and to implement appropriate statistical analysis strategies for a wide range of health outcome studies. Participates in client communications. Requires minimal supervision.
Key Skills and Attributes
• Plans, coordinates, and performs statistical analysis for segments of complex project assignments.
• Works collaboratively on most phases of biostatistical and/or psychometric analysis, and provides guidance to less-experienced statistical programmers.
• Provides guidance to project staff on biostatistical and psychometric aspects of projects.
• Accountable for basic and complex statistical design and analysis, such as determining sample size, variance estimations (weighting), sample design, statistical modeling, latent class analysis, cluster analysis, structural equation modeling, growth mixture models, item response theory, Rasch analysis, and other biostatistical and psychometric analyses.
• Ensures quality control of the contributions to client deliverables, including the display of analytic results in graphics and tables subsequently formatted for client presentation.
• Designs, develops, and documents technical and operational procedures and statistical analyses.
• Assists the project team in the preparation of statistical analysis plans, project reports, manuscripts, and presentations.
• Understands of current requirements for regulatory guidelines to assist with regulatory submissions, and assist PIs in preparation for regulatory meetings and respond to questions from the FDA and other regulatory authorities on statistical issues.
• Applies advanced knowledge of statistical procedures, psychometric methods and their applications, and statistical programming (e.g., SAS, Mplus, RUMM2030, MULTILOG).
• Interacts with clients and participates in meetings as necessary to discuss statistical aspects of projects, or to present and discuss results.
• Works effectively as a member of a team in a consulting environment.
• Approximately 10% travel time expected.
• Experience in the statistical and psychometric analysis, interpretation, and reporting of results of clinical, observational, or outcomes research data.
• Knowledge of multivariate statistical techniques, psychometric analyses, cluster analysis, latent class and growth mixture modeling, Rasch analyses, and IRT analyses as required; exposure to meta-analysis is desirable.
• Sound theoretical foundations in the instrument development and validation process.
• Ability to successfully communicate with and advise clients.
• Ability to demonstrate advanced scientific leadership and direction to project teams and statistical programmers.
• Ability to work on multiple complex projects simultaneously.
• Manages internal timelines to ensure that deliverables meet external client timelines.
• Manages assigned staff hours per project so as not to exceed contracted budget.
• Knowledge of project management systems (electronic and paper filing, SOP requirements, finance office practices, etc.).
• Ensures project compliance with all study documentation, including paper and electronic filing.
Financial & Business Development
• Leads, reviews, and finalizes statistical programming needs for project proposals, including budget.
• Meets annual target utilization rate of 70%, unless otherwise specified.
OR Operations Support
• Attends and presents at scientific conferences.
• Develops and presents internal scientific trainings.
• Participates in staff recruitment efforts for other statistical programming positions, as needed.
• Conforms to SOPs requirements.
• Participates in special assignments (e.g., job descriptions, handbook updates, SOP scientific consulting, etc.).
• Develops client relationships.
• Contributes to scientifically rigorous deliverables that best help clients meet their objectives.
• Works with PI to help identify statistical and psychometric methods/plans that help clients meet their goals, as well as those that will not help clients meet their goals.
• Assist PIs in preparation for regulatory meetings.
• Ph.D. in Statistics, Biostatistics, Education Measurement, Psychometrics, Psychological Measurement, or related field with an emphasis on quantitative analysis and psychometrics.
• Advanced training in psychometric research and statistics, including item response theory, scaling and equating, Monte Carlo methods, structural equation modeling, latent class analysis, and growth mixture models.
• Knowledge of pharmaceutical industry standards such as ICH guidelines, SDTD, CDISC, etc and responds to questions from the FDA or other regulatory authorities on statistical issues.
• 5-10 years of increasingly responsible professional experience.
HOW TO APPLY:
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Equal Opportunity Employer, M/F/D/V
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