Job Category: Clinical: Biometrics
Job Number: 2175
Our client is looking to add an Associate Director / Director (depending on level of experience) of Biostatistics to their team on a permanent basis. S/he will manage the daily activities of the biostatistics staff, to ensure everyone is well-trained on standard processes and to promote efficiency, quality, and timeliness in project work.
- Participates in proposal development for programs and/or new drug applications (NDAs).
- Represents biostatistics on operational committees for FSP opportunities.
- Responsible for staff career growth and development.
- Monitors staff projects quality, timeliness and budgets to foresee and correct issues and assure project expectations are met.
- Manages resources within team: new hires, terminations, transfers, and contractors.
- Summarizes growth and programs to be considered in the annual budget.
- Acts as the primary leader within a region.
- Participates in internal and client audits.
RESPONSIBILITIES / QUALIFICATIONS:
- An advanced degree (M.S. or Ph.D.) from an accredited institution in statistics, biostatistics, pharmaceutical sciences, biology, or a health-related field
- 9 years of leadership experience in biostatistics at a CRO or pharmaceutical company, including 5 years of formal people management experience
- Demonstrates project leadership and ability to manage technical staff
- Understands computerized systems (SAS), PC-Windows, and Word
- Displays excellent written communication and presentation skills
- Exhibits knowledge of advanced biostatistical methodology
- Demonstrates knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP)