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Job #02868

About our client Our client is a diagnostics company based in California. They offer products and services used by the industry to assist with the diagnosis, treatment and management of infectious diseases. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Biostatistician Cypress, South Carolina Salary Highly competitive package, commensurate with experience Responsibilities 1) Establish statistical methodology on product development, clinical trials, validations and process improvements 2) Support the organization in statistical methodology and analysis 3) Ensure statistical validity of regulatory submissions and publications 4) Support all applicable regulations and standards (domestic, international and ISO requirements) 5) Work with company personnel to identify, isolate and correct technical challenges for improving product and process reproducibility 6) Serve as a statistical methodology expert for the organization 7) Provide input (as requested) for changing procedures and updating processes 8) Improve understanding and utilization of statistical tools and methods throughout the organization 9) Write statistical sections of protocols (development, validation and clinical trials) and marketing materials 10) Interact with regulatory authorities on statistical regulatory issues (as required) 11) Create experiment design plans 12) Perform sample size calculations and provide justification of sample sizes 13) Compile statistical methods for studies (validations, clinical studies and process data analysis) 14) Provide data analysis for research, process and product development and manufacturing processes to determine the appropriate statistical method 15) Communicate statistical issues and solutions with Pre-Clinical and Clinical Development Team 16) Assist in quality reviewing of data to confirm its suitability for the intended purpose or analysis 17) Develop data collection systems to facilitate efficient data analysis 18) Review clinical study data to confirm appropriateness 19) Verify methodologies used for data collection and analysis 20) Monitor new methodologies and statistical techniques for the statistical analysis of clinical data 21) Develop and present training and training materials on statistics and related topics 22) Assist with evaluating, purchasing and implementing statistical and process control system software as well as related tools 23) Perform assigned tasks in accordance with applicable safety regulations and instructions as well as correcting unsafe work habits and practices 24) Inform the Safety Team or a Supervisor of any practice/condition that may be detrimental to the safety and health of the employees 25) Cooperate in all safety or health-related programs and assist in solving safety and health problems 26) Handle violations of safety directives and procedures as per established company disciplinary process 27) Perform other duties as assigned Requirements 1) Bachelor’s degree in Statistics, Biostatistics, Mathematics or Computer Science (Master’s degree in Statistics or Biostatistics preferred) 2) Minimum 5 years of experience in IVD, medical, pharmaceutical or other related industry 3) Expertise in design of experiments (DOE), nonlinear or logistic regression, reliability analysis, categorical data analysis as well as Six Sigma and their application as problem identification and resolution tools 4) Working knowledge of biological and clinical sciences preferred 5) Knowledge of FDA, international regulations for design, conduct and analysis of clinical trials 6) Knowledge of applied multivariate analysis, control theory, time series analysis, regression, ANOVA and mixed models as well as data mining techniques 7) In-depth understanding of statistical quality control, SPC and sampling strategies 8) Computational programming/simulation skills preferred 9) Excellent project management and communication skills to supervise the work of others, consulting and submission/publication preparation, and review 10) Ability to plan and implement statistical analyses independently as well as use knowledge of clinical development and regulatory processes to advance projects