Description
Sr. Director/Director of BiostatisticsThe Ideal candidate for this role will have 4-5 years experience in a leadership role. They will have gone through multiple FDA submissions and be familiar with both the Medical Device and Pharmaceutical Industry. This is a permanent, onsite role in Southern California.
Position Details:
- Routinely keep track of revenue captures for statistical services under supervision and keep supervisor informed.
- Responsible for statistical activities associated with clinical research studies and with programs leading to regulatory submissions.
- Represents the company at FDA meetings.
- Assist in administration of the department, including resource and project scheduling, interviewing and hiring, establishing departmental processes, interaction with other departments.
- Review and approve work of other members of the department.
- Perform Employee Performance Appraisals.
- Ensure consistency of departmental activities and processes across projects.
- Plan and implement process improvement goals within the department.
- Maintain departmental SOPs and technical documentation.
- Plan and implement technical training for other members of the department.
- Coach and develop staff members for professional enhancement.
- Monitor timeline and keep track of revenue realization for all supervised projects.
Position Requirements
- Ph.D. in Statistics/Biostatistics or equivalent.
- At least 10 years Pharmaceutical Industry experience
- Supervise statisticians up to Associate Director Statistician level.
- Proficient in statistical procedures including non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques
- Proficient in SAS.
- Strong oral and written communication skills and excellent interpersonal skills.
Please apply if interested!