Description
Primary Responsibilities:Plan, organize, supervise, and coordinate statistical activities for specific segments of clinical projects in support of product development and U.S. and international product registrations.- Oversee daily activities of Biostatistician and contract statistical resources.
- Responsible for statistical integrity and accuracy of clinical studies.
- Interact with FDA or other regulatory agencies as appropriate in statistical aspects of study design, data analysis, and choice of statistical methodologies.
- Provides appropriate statistical advice and support to clinical researchers consistent with prevailing standards for good statistical methodology, regulatory, and departmental guidelines.
- Coordinate and provide quality oversight of contract research organization in activities related to data management and statistical analysis.
- Assist in training and support of clinical trial professionals from other functional areas in regards to basic statistical concepts necessary for the conduct of clinical trials.
- Participate in the development of process/manufacturing validation protocols with respect to sample size consideration and methods of proposed analysis.
- Summarize and present data internally and externally.
- Participate in Human Resources activities for the department (staffing, performance management and employee development)
Qualifications/Requirements/Skills:
- Ph.D. in Biostatistics or Statistics with a minimum of 10 years experience or a Master's degree with a minimum of 14 years experience in the pharmaceutical/biotechnology industry in support of phase 1-3 clinical studies.
- Experience with major statistical software packages (including SAS).
- Previous experience managing statistical staff.
- Excellent communication skills with the ability to interface at all levels, both within Cerus and with outside organizations.
- Ability to integrate statistical and biomedical concepts.
- Ability to influence upwardly by working with department heads and senior management.
- Ability to delegate to lower level staff members.
- Strong attention to detail and accuracy.
- Time management skills (timelines, schedules, task prioritization).
- Flexible; ability to adapt to changing priorities.
To find out more about Real, please visit www.realstaffing.com