Job Title: Director, Biostatistics Position Description
- Manages the daily activities of the biostatistics staff, to ensure everyone is well-trained on company standard processes and to promote efficiency, quality, and timeliness in project work.
- Participates in proposal development for mid-size programs and/or new drug applications (NDAs).
- Represents biostatistics on operational committees for mid-size 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.
- 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).
- Master's degree in statistics or biostatistics
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.