Principal Statistical Associate - Biostatistics

Job Responsibilities

• Lead, support, and collaborate with sponsors, external investigators and other staff on the development and review of study protocols, including the selection of appropriate trial/study designs and statistical methodology with special emphasis on Bayesian methods.
• Develop study aims and research hypotheses and assess appropriateness and feasibility.
• Estimate optimal sample size for the desired power, recognizing resource limitations of individual research studies.
• Develop statistical considerations and analysis methods for study protocols.
• Develop statistical analysis plans for research projects including guiding the data management team in terms of database design, selection of statistical methods, creation of project timelines, and development of formats for presenting results.
• Oversee, lead, and consult on all phases of analytical programming, data management, macros, quality control and reporting of research data.
• Conduct statistical analysis for clinical trials, clinical studies and epidemiological projects including implementation and refinement of statistical methods, preparation of formatted tables of results and other outputs, verification of the accuracy of results, and assumption of primary responsibility for the analysis and presentation of project data.
• Lead efforts in researching, recommending, and implementing methods to validate, troubleshoot, and interpret results.
• Participate in quality control and quality assurance processes and review code output, tables, and charts.
• Present analytic results orally and in writing to internal and external audiences, incorporating descriptions of methods, relevant literature, and other background material to provide context for the results.
• Serve as a data resource for research project teams and interact directly with clients and external investigators.

Basic Qualifications

• PhD in Biostatistics or a related quantitative field of study and 5 years of post-doctoral relevant experience, including 1-2 years in the design, analysis, interpretation, and reporting of clinical trials.
• Experience in health research, advanced data analysis, and in analyzing research data using statistical packages.
• Experience with R, SAS, and other statistical packages.

Preferred Qualifications

• Deep knowledge and experience in the application of Bayesian adaptive and SMART designs and approaches to clinical trials and clinical interventions, including simulation planning and the use of synthetic data.
• Proven ability to plan, direct, develop and present statistical analysis plans.
• Demonstrated capability to work in study teams, oversee staff, and guide others in application of statistical methods.