Description
Provide statistical support for projects of moderate to difficult scope and complexity. Use statistical knowledge to influence business and strategic decisions. Find/create and communicate best practices for BD statisticians. Provide technical leadership through mentoring others and/or directing advancements in area of expertise. Identify and fulfill training needs for non-statistical professionals. Keep abreast of new statistical developments; survey related fields for techniques that could be adapted to BD's needs; may make presentations or publications for industry-related conference and journals; represent BD with FDA and other regulatory bodies. Develops/revises work plans independently.
Consults with clinical and project teams; apply extensive statistical expertise in order to develop plan and analyze of moderate to difficult clinical studies and use results from clinical studies to address business issues. May be required to program new applications and/or extend current ones. Expected to present and potentially defend analyses and interpretations to internal and external customers. Establishes and maintains sound working relationships with other functional groups.
Collaborates with the clinical team on Case Report Form design, Query design, data cleaning definitions, and protocol deviation resolution. Performs interim analyses as required. Provides required study documentation, write reports and make oral presentations as required.
Provides statistical support and guidance to the clinical management and project teams to facilitate strategic decision making.
Leads and mentors other statisticians. Is responsible for coordinating statistical support for particular projects, and may direct activities of other statisticians and programming personnel as required by the project or program.
Represents BD or guides other statisticians in interactions with FDA, other regulatory bodies, and other external organizations (eg. Advanced Medical Technology Association (AdvaMed), Clinical and Laboratory Standards Institute (CLSI)). Reviews external guidance documents and provide appropriate feedback.
Keeps abreast of new statistical techniques and determine if they could be adapted to BD needs. Determines which statistical method/study design to use on new and/or complex trials.
Qualifications
EDUCATION AND EXPERIENCE:
· Ph.D. or M.S. in Statistics, Biostatistics, Mathematics, or closely related discipline will be considered. At least three years of experience with PhD in statistics or at least five years of experience with MS in statistics in a regulated industry with device, diagnostic, and/or pharmaceutical experience recommended. Equivalent education or experience will be considered.KNOWLEDGE AND SKILLS:
· Extensive knowledge in mathematical statistics and strong technical knowledge across multiple areas of statistical practice (eg. experimental design, clinical trial design, linear statistical models, generalized linear models, logistic regression, applied probability, and categorical data analysis) is required.
· Knowledge of supporting in-vitro diagnostic (IVD) clinical trials is desirable.
· Strong knowledge in Bayesian inference, algorithms, nonparametric statistics, nonlinear regression and empirical modeling, modern regression methods, optimization, multivariate analysis, simulation, Six Sigma continuous improvement, statistical quality control, and survey sampling are desirable.
· Working knowledge of SAS is required. Knowledge of Splus/R, Matlab, C++, Visual Basic, or other programming languages is desirable. Working knowledge of Windows operating systems is required.
· Demonstrated ability to match challenging, complex experimental-design or clinical-trial problems with statistical strategies that are effective and appropriate is required. Strong ability to defend that choice, with an ability to communicate clearly the merits and demerits of competing statistical strategies, based on both statistical theory and clinical considerations is required.
· Familiarity with regulations that applied to the Medical Device Industry such as: Good Clinical Practice Guidelines, ICH standards for clinical trials, and FDA regulations for clinical trials is required.
· Ability to independently provide statistical guidance and make statistical conclusions to teams is required.
· Ability to lead statistical discussions with the regulatory agencies is required.
· Ability to guide other statisticians in their interactions with teams and regulatory agencies is required.
· Strong interpersonal skills is required. Demonstrated ability to be collaborative and resourceful with good listening and negotiation skills is required.
· Demonstrated capability of working on multiple projects at one time is required.
· Strong oral and written communication skills is required.
· Coursework in physical, biological, or social sciences is desirable.
· Publications in statistics journals is desirable.
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