Description
Senior BiostatisticianA great medical device company in the San Francisco Bay Area is urgently looking for an experienced candidate to fill a Senior Biostatistician position. This is an excellent opportunity to join a growing company with an excellent pipeline.
Senior Biostatistician Duties:
To participate in the planning, implementation and coordination of the design of protocols, case report forms, and clinical procedures for the efficient data collection, management and evaluation of clinical studies conducted by the business unit, and to execute the analysis of data from these studies. To participate in the documentation of the study results in clinical reports for various regulatory submissions. To participate in the preparation of abstracts, oral and poster presentations, and publications relating to the study results. To ensure that clinical studies are conducted and data analyzed in accordance with good clinical practices Position Responsibilities: Work with the Coronary and Renal Denervation business unit's clinical and project teams to develop and refine study objectives to primarily establish safety and efficacy, and secondarily, quality of life and cost-effectiveness related data for clinical trials. Participate in the development of the study protocol with primary responsibility for statistical hypotheses, sample size, and analysis plan for meeting the study objectives. In collaboration with the management team, , select appropriate study design for optimal power, hypotheses, endpoints, critical differences, procedure specifications for clinical evaluation. Further, to estimate baseline endpoint rates in the control group through literature review, analysis of historical data, or gathering of expert opinion to generate sample sizes and follow-up times to meet study objectives. In addition, to choose analysis plans, and determine whether fixed-sample or sequential analyses will be used. To specify stratification variables and covariables for adjustments, analysis times, data monitoring specifications, and analyses of additional performance measures.
Participate in the design of case report forms to ensure data validity and usefulness, and to assist with the development of the core clinical procedures of the study protocol to ensure the ascertainment of the quantitative data requirements of the study.
This company is looking to fill this role of a Senior Biostatistician as soon as possible. If interested please respond to this post and get this wonderful opportunity started.
To find out more about Real please visit www.realstaffing.com