Biostatistician

Job Summary:

The successful candidate will manage all aspects of the Company's clinical data management effort:

* Contribute to the development and maintenance in the Biostatistics group of methods and procedures based on Regulatory Guidelines and Company requirements
* Participate in Clinical Study Team meetings for assigned studies
* Responsible within the Clinical Study Team for the quality, accuracy and timely completion of assigned tasks
* Support R&D and other departments by providing statistical expertise for issues in preclinical and clinical research
* Assist in statistic model selection, experimental design, design and analysis of clinical trials
* Analyze and interpret data from individual trials
* Perform meta-analyses by pooling data from several studies
* Develop project analysis plan, including computer-generated table specifications, statistical analysis plan, and research report format
* Co-operate in further development of internal guidelines and SOPs
* Prepare project summaries for weekly/monthly project review meetings
* Update knowledge in statistical concepts, methods, and techniques
* Maintain state of the art statistical applications in clinical research
* Responsible for data processing for accurate relocation, formatting, generating and transmitting required data
* Prepare statistical contribution to study reports
* This is a managerial role directing other clinical and regulatory professionals, including contract research organizations, involved in the Company's clinical efforts, and integrating those efforts with other departments within the Company.

Job Requirements:

* The position requires unparalleled attention to detail and organization. Strong communication skills, a team player and a healthy dose of common sense are essential qualities for the position. You will regularly interact with regulatory agencies, physicians and other scientists involved in clinical research. You will regularly assemble clinical data and participate as a key resource in the Company's product development and commercialization efforts. Specific requirements include:
* BA/BS in a clinical, scientific, or related field, advanced degree preferred.
* A minimum of 4 years of clinical project management experience required, preferably with class-III, PMA-track devices and studies.
* Experience with electronic data capture (EDC) systems, SAS programming and related statistical tools
* Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations and GCP guidelines is required.
* Excellent planning and problem solving skills.
* Excellent written and verbal communication skills and ability to communicate effectively with all levels of the organization.
* Ability to travel up to 30%, based on project needs.
* Proficiency with Office Suite and standard computer programs required.
To find out more about Real please visit www.realstaffing.com