Description
Job Responsibilities:- Work collaboratively with team members to coordinate the planning and execution of biostatistics deliverables
- Support the preparation and validation of datasets that are of high quality and CDISC-ready
- Provide requirements to SAS Programmers to facilitate efficient and effective programming
- Be responsible for quality assurance of data produced, the validity of the reported results and their statistical interpretation
- Apply statistical expertise in the critical review of data and data analyses and in support of regulatory submissions and responses
Requirements:
- Masters or Ph.D. in statistics with at least 5 years of experience in the pharmaceutical or biotech industry
- Demonstrated ability to effectively contribute to the statistical aspects of data interpretation, review and reporting of results for multiple studies and projects
- Practical experience with application of advanced statistical methodologies to clinical trial analysis and with regulatory reporting/submissions
- Proficiency with statistical software tools such as SAS, S-Plus, R, EAST
- Familiarity with regulatory requirements and considerations (e.g. GCP, ICH, 21CFRpart11, CDISC)
- Positive interpersonal work habits and communication skills
- Ability to work independently and act with initiative to address issues
- Ability to communicate statistical concepts in a clear and concise manner
- Excellent verbal, writing, and presentation skills
To find out more about Real please visit www.realstaffing.com