Title: Statistician II Duration: 03 Months Location: Minneapolis, MN 55432 This project will mainly consist of setting up programming code based on the pre-existing SAP drafts and the draft report/table shell, but may require independent thinking on aspects of the analysis. The project will also likely include validation of code from the internal statistician. Position description: The Senior Statistician will be responsible for statistical aspects of study design and analysis of data from clinical studies conducted for regulatory approval or marketing purposes. This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts. Work will generally be done independently, but will be reviewed by the Manager at key time points. Position responsibilities: • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature. • Prepares relevant sections of protocols, especially those detailing the plans for data analysis, and justification for the sample size. 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 team to prevent, track, and manage potential problems. • Writes the statistical analysis plan for the study, if required. Also writes error-checking requirements for the study data. • Takes responsibility for responding to relevant questions from FDA. • Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods. Methods must be appropriate for the kind of data collected, and required assumptions must be tested. • Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected. • Validates and provides clear documentation of analysis programs. • Writes Results and Methods sections of reports and manuscripts as needed. • Consults with other (e.g. non-clinical) staff on statistical and analysis issues. • Attends and contributes to project and department meetings.
Basic qualifications: Bachelor's degree in Biostatistics or Statistics and 5+ years of experience in analysis of data from clinical studies and design of clinical trials OR Master's degree in Biostatistics or Statistics and 3+ years of experience in analysis of data from clinical studies and design of clinical trials. Desired/preferred qualifications (optional): • Specific coursework in Clinical Trials or Epidemiology. • Experience in study design in the medical device or pharmaceutical industries • Knowledge of relational database function, and SAS Proc SQL. • Strong applied statistical skills, including survival analysis and regression modeling • Advanced programming skills in SAS, or another statistical analysis package • Knowledgeable regarding research data management • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel) • Demonstration of good oral and written communication skills. • Well-developed interpersonal skills
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