Job Description:

Position will design, develop and evaluate the technical and statistical infrastructure for the conduct and evaluation of clinical trials, including the coordination of all related areas and activities; improve processes, protocols, and Statistical Analysis Plans (SAPs); lead team in experimental design, protocol development, SAPs, and analysis to meet project objectives; create statistical analysis of clinical study reports, NDAs, INDs, and annual reports; serve as contributing member on critical project teams with Clinical Data Managers, Statistical Programmers and other MDG management responsible for meeting study objectives; determine best methods and techniques for complex analysis design; provide estimates of project resource requirements and timelines; conduct briefings and participate in technical and regulatory meetings with relevant representatives.

Qualification:

The position requires a Ph.D. (or foreign equivalent) in Biostatistics, Statistics, or a related field plus one (1) year of experience in the job offered or in a related position. Alternatively, employer will accept a Master's degree (or foreign equivalent) in Biostatistics, Statistics, or a related field plus three (3) years of experience in the job offered or in a related position. Experience must include demonstrable knowledge of the following: Demonstrable experience leading statistical activities, managing study timeline and resources, and coordinating study activities with other functions; Demonstrable knowledge of clinical trials; Demonstrable experience with R language commonly used in clinical trial design and data analysis; Demonstrable experience with SAS language, procedures, and options commonly used in clinical trial reporting including BASE SAS and SAS/STAT; demonstrable experience with CDISC SDTM and ADaM models and conducting statistical analyses using SDTM/ADaM; demonstrable experience designing and conducting statistical simulations to address key strategic questions in clinical trials; demonstrable strong independent statistical research capacity including literature review, authoring peer-reviewed statistical and/or medical papers.

Send Resume to Shannon Holt at ...@vrtx.com. Reference 12140.186
Associated topics: bioinformatics, biometrics, biostatistics, data analyst, data science, sas, statistics

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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