Master’s degree in Statistics or Biostatistics with at least two years related experience Skills:Required PHARMACEUTICAL FDA SAS STATISTICAL ANALYSIS BIOSTATISTICS Minimum 2 years experience in BIostats role within Pharamceutiocal or Diagnostics industry. Minimum 2 years Manufacturing and product development Pharmaceutical/Biotechnology industry experience (assay validation, product specification setting, OOS, SPC, process optimization, etc.). Minimum 2 years experience managing people in a Biostats or clinical capacity. Demonstrated sound knowledge of statistical applications to clinical and nonclinical projects. Demonstrated technical expertise across a range of commonly used statistical methodology. Knowledge of appropriate regulations and guidance documents. Broad experience across a range of clinical and nonclinical projects and demonstrated support of diverse client needs. Demonstrated management and leadership skills. Demonstration of innovation by development or novel application of statistical methods. Sound knowledge of theoretical statistics and statistical applications Must have proficiency as an SAS programmer Knowledge of FDA regulations and guidelines is a plus. Good communication and presentation skills. Ability to work effectively in both in a team environment and independently. Ability to work on several projects simultaneously. Possess good problem solving skills. Self-motivated Capable of addressing unique problems Experience in the diagnostics area is preferred. * Developing consultation skills that include design, and data management issues for clinical and nonclinical projects. Work with project teams to produce protocols, analysis plans and final reports for clinical and nonclinical projects. Plan, coordinate and produce statistical analyses, summaries and write formal memoranda. Produce SAS programming and other software package programming to analyze data. Interpret the project implications of regulatory guidelines. Interact with FDA, other regulatory or auditing agencies as appropriate in statistical aspects of study design, data analysis, and justification of statistical procedures. Represent Biostatistics on company-wide project teams. Serve as primary liaison between Biostatistics and key internal clients with regard to resource needs and timelines. If appropriate, interact with counterparts at companies collaborating with other Teams including proactively engaging with joint development corporate partners. Initiate methodological research in statistics to improve biostatistics methodology used in development products consistent with corporate priorities and timelines. Develop Clinical and Nonclinical Biostatistics procedures and guidelines to comply with corporate policies and procedures. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr
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