Project Biostatistician The Project Biostatistician will work collaboratively with data management, drug safety, clinical operations, and clinical research organization (CRO) staff to participate in the design, execution and analysis of clinical trials. This position is responsible for providing biostatistical and SAS programming support for ongoing study management, as well as analyses for publications and regulatory submissions. Primary Responsibilities: Work with the study team to plan and perform statistical analyses for clinical trials. Provide statistical, clinical trials methodology and regulatory input (e.g., trial design input, sample size calculations, randomization, statistical methods, CRF design and data consistency checks). Produce, implement, validate and manage the statistical analyses as defined in statistical analysis plans for clinical trials. Generate tables, listings and figures, conduct statistical analyses, interpret clinical trial data, and communicate statistical results and concepts to non-statisticians. Work to maintain, and define departmental standards in reference to processes, procedures, templates and guidelines related to biostatistics and programming. Participate on interdepartmental protocol teams and function as an advisor on all protocols and tasks. Job Qualifications Education: Masters degree, preferably in a statistics, epidemiology or related environment. Experience: Minimum of 3-5 years experience in the pharmaceutical, biotech, or CRO industry. Knowledge: A strong understanding of data analysis and reporting requirements for clinical trials Excellent knowledge of SAS programming, including validation techniques. Candidate should be able to plan, coordinate, conduct, and oversee statistical activities, both internally and externally (CRO). Knowledge of clinical research procedures and FDA regulations. General knowledge of industry data management practices and standards, including familiarity with Clinical Data Interchange Standards Consortium (CDISC). Skills: Problem-solving abilities, time management skills and initiative. Must be precise, detail oriented, and work well under pressure. Must be able to work independently as well as be a team player. Excellent verbal and written communication skills. General computer skills including Microsoft Office and Adobe Acrobat. Submit Resume >> | Return to Careers >>