Senior Biostatistician

Job Description

What you'll be doing Create, test and maintain SAS codes used to create and/or validate statistical outputs for the cardiac safety statistical analysis; create and maintain procedures for creation of TFLs/ statistical outputs; provide statistical support under the supervision of senior team resources and/or department management; may supervise staff in a line management or matrix capacity. Develop, test, execute and maintain SAS and R programs for statistical analysis including central tendency analysis, categorical analysis, and concentration-QTc analysis Validate results of statistical analysis by double programming Prepare tables, figures, and listings for statistical analysis as outlined in the statistical analysis plan Perform review of final outputs and reports as it relates to the planned statistical analysis Perform quality checks on CDISC formatted analysis datasets (ADaM) Support research programs and provide research results to the senior team resources and/or department management Provide interpretation of results/reports of statistical analysis including descriptions of methodologies and conclusions to the Principal/Sr. Principal Biostatistician, Medical Writing, and/or Scientific Team Train team members on standard operating procedures and standard methodology Develop process improvements to increase overall operational efficiency Drive ideas for future analyses and data quality efforts What we're looking for A PhD in Statistics, Mathematics or equivalent A Masters degree in Statistics, Mathematics or equivalent and 4+ years of relevant industry experience Bachelor’s degree in Statistics, mathematics or equivalent with 10+ years of relevant industry experience. Familiarity and experience with ANOVA, t-test, regression, and linear mixed-effects modeling. Strong SAS or R programming skills. Experience in clinical trials within a CRO or pharmaceutical research organization Familiarity with Clinical protocols and Statistical Analysis Plans, understanding of the pharmaceutical drug development process Excellent verbal and written communication skills. Awareness of CDISC SDTM and ADaM standards. Strong organization, analytical and communication skills.