45927-4677 - Statistician
Location: Saint Paul
Posted on: May 18, 2023
Requisition # : 45927-4677
Start Date : 1/12/2015
End Date : 11/30/2015
Over Time Allowed : No
Interview Type : Interview
Travel : No Travel Required
Environment : Professional
Schedule : Typical 8 Hour/Day
Dress Code : Business Casual
Work Location : Mounds View, MN 55112
Labor Category : Clinical, Scientific and Laboratory Research
Job Family : Statistics
Job Title : Statistician
Job Duties :
-The statistician is responsible for data analyses and statistical aspects of studies conducted for regulatory approval or marketing purposes.
-This includes responsibility for writing statistical analysis plans, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts.
-This also includes design of studies, calculating of sample size and power, writing statistical portions of protocols, review of protocols and case report forms, support for research, physician, and marketing requests, and assisting clinical teams with other duties as appropriate
-Uses a variety of statistical methods and software tools to analyze and display data.
-Methods must be appropriate for the kind of data collected, and required assumptions must be tested
-Interprets statistical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected
-Validates and provides clear documentation of analysis programs
-Writes portions of Results and Methods sections of reports and manuscripts
-Consults with colleagues on statistical and analysis issues
-Writes the statistical analysis plan for the study.
-Writes error-checking requirements for the study data
-Applies statistical knowledge to the design of clinical studies.
-This requires calculation of sample size and power, as well as solicitation of appropriate design assumptions from other staff and from published literature
-Reviews entire protocol for consistency
-Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
-Identifies potential threats to study credibility and validity, and works with study teams to prevent, track, and manage potential problems
-Assists study teams in responding to questions from FDA.
-Attends and contributes to project and department meetings
-Perform statistical program validation in accordance with departmental Standard Operating Procedures
-Identify potential threats to study credibility and validity, and work with study teams to prevent, track, and manage potential problems
-Work with the information systems staff and the clinical study team to develop specifications for the database design that assure the quality, integrity, and timely availability of the data for monitoring and analysis purposes
-Manage multiple, varying sized projects concurrently
-Work with cross-functional teams to develop and refine study objectives to establish the safety and efficacy of medical device therapies and diagnostics
-Participate in development and documentation of study protocols with responsibility for scientific soundness sections, which include statistical hypotheses, sample size calculations, and analysis methods for meeting the study objectives, in collaboration
-Perform analyses of study data including documentation and justification of the statistical methods, analyses, and results in clinical reports, abstracts, and manuscripts
-Respond to statistical questions from FDA/other regulatory agencies
-Develop statistical programs (e.g., using SAS, S-PLUS, R, WinBUGS) for data extraction, statistical analysis, and report generation.
*Education Level: Master of Science
*Industry Experience: 1 - 3 Years
*Oral Communication: Excellent
*Software Application Knowledge: SAS
*Written Communication: Excellent
Request Notes :
*MUST HAVE a MS in Statistics, Biostatistics, or related field with 7-11 years of experience in the design and analysis of clinical studies or 4-8 years with a PHD, advanced programming skills in SAS, knowledge of clinical trial methods and execution in a regulated environment, demonstration of strong oral and written communication skills, including experience presenting clinical trial results and statistical methods.
*Primary focus will be on the design and evidence dissemination of clinical studies.
*Ensure clinical protocols and statistical methods meet sound and efficient statistical and clinical trial methodologies.
*Work with cross-functional teams to develop and refine study objectives to establish the safety and efficacy of medical device therapies and diagnostics.
*Participate in development and documentation of study protocols with responsibility for scientific soundness sections, which include statistical hypotheses, sample size calculations, and analysis methods for meeting the study objectives, in collaboration with others.
*Stay current on clinical evidence landscape and oversee dissemination efforts of abstracts, oral and poster presentations, reports, and publications. Interact with FDA reviewers, especially statistical, to negotiate appropriate study designs, to explain the quantitative results of clinical studies, and to defend the analytical approach.
*Actively participate with internal and external governing bodies of clinical trials (e.g. Steering, Publications committees, etc.).
*Mentor and train other statisticians in their job duties and responsibilities.
*Remain current on state-of-the-art statistical methods useful in clinical trial design and analysis and share knowledge within the department.
*Lead development of policies and procedures for the department and the statistics group.
*Perform statistical program validation of important endpoints in accordance with departmental Standard Operating Procedures.
*Identify potential threats to study credibility and validity, and work with study teams to prevent, track, and manage potential problems.
*Review statistical analysis plans.
*Review case report forms and ensure consistency between the data collected and the objectives of the study.
If you are interested in this opportunity and you qualify please complete the following and send back with your updated resume.
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Requirement #: 45927-4678
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Requisition # : 45927-4677
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