Remote - Biostatistician - Experis - Chicago, IL

Nov 26, 2019
Experis, Chicago, IL

Job Description

The statistician develops appropriate statistical methods for data analysis and ensures the accuracy and reproducibility of data sets and analyses of studies or registry data by following relevant work practices and procedures. The statistician may participate on project teams as the lead statistician on one or more multi-protocol projects within a therapeutic area. The statistician communicates with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results. J Job function and description ensures all statistical work is processed on time to appropriate quality levels, reviews project protocols, authors protocol statistical analysis sections, including sample size calculations or simulations. Generates and/or coordinates the creation of randomization schedules and ensures their accuracy. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical analysis plans for studies or registry studies with fully documented table, listing, and figure shells. Specifies statistical terms, equations for derived variables and algorithms for analysis Prepares documentation/specifications to support SAS code for analysis programs Understands and has the ability to use advanced statistical methods. Leads the analysis and reporting of results for studies or registry database, which may include ISS and ISE, annual reports and/or other regulatory documents. Verifies statistical programs, data sets used and statistical results in regulatory documents and other reports Develops SAS programs as necessary to perform planned or ad hoc analyses and prepare data displays Produces statistical reports as required Provides statistical interpretation of results and explains statistical methodology to team members Discusses statistical aspects of studies with regulatory authorities. Assists in the Development of SOPs pertaining to statistics and SAS programming, consistent with FDA and ICH regulations and guidelines. Participates in and/or leads process/quality improvement initiatives Provides leadership, quality review, and mentoring to less experienced statisticians which may include coordinating the work of other statisticians and/or programmers. Helps with the recruitment of statisticians Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings. Presents and discusses the statistical aspects of clinical trials to professional organizations, e.g. FDA reviewers, or less technically oriented audiences. Key Skills, Abilities, and Competencies: Excellent knowledge in Statistical Theories and Methodologies as applied to Pharmaceutical Sciences. Strong knowledge of SAS programming, good analytical skills, ability to communicate technical concepts clearly, concisely, and understandably to non-statistical colleagues. Sound understanding of regulatory guidelines in a pharmaceutical research setting. Skills: - Experience with statistical software packages such as SAS and S-Plus in both PC and Unix platforms. - Familiar with Microsoft-Office such as WORD, EXCEL and Power-Point - Sound knowledge of theoretical and applied statistics. - Sound understanding of regulatory guidelines in a pharmaceutical research setting. - Effective skills in communication and team collaboration. Ph.D. in Statistics/Biostatistics or related fields with at least 2 years in biotech/pharmaceutical industry (or Master with at least 5 year experience) Experis is an Equal Opportunity Employer (EOE/AA) Save

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