Director Biostatistics
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Summarized Purpose:
Provides operational leadership for the department. Evaluates workloads resources processes and technologies for efficient operation of the department. Ensures systems are in place to produce quality work efficiently allowing for continual growth of department. Consults with project teams sponsors and other clients/agencies on project-related issues. Acts as the senior reviewer or project oversight on multiple projects.
Essential Functions
Manages staff which may include interviewing and selection job description preparation professional development goal setting performance management behavioral and technical coaching and mentoring employee counseling and separations. Approves courses of action on salary administration hiring corrective action and terminations. Reviews and approves time records expense reports requests for leave and overtime. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good scientific ethical and regulatory standards.
Acts as senior reviewer on multiple projcts manages project team resources budget finance timelines and ensures SOP compliance with appropriate documentation.
Serve in the a project oversight role management role of project oversight for studies to represent the study(s) to all functions as needed with client and fully accountable for all aspects of the management of risk.
Informs senior leaders of department activities accomplishments and needs.
Participates in long-range strategic planning development of departmental business plan and departmental budget.
Prepares bids for marketing and business development.
Communicates company and department policies and priorities to department staff and assuring compliance.
Ensures appropriate personnel resources are applied to department projects based on priorities and relative complexity.
Provides statistical consultation and serves as senior reviewer on projects.
Reviews and/or approves documents related to project activities.
Participates in project development and FDA meetings concerning investigational and marketed drugs assigned to the department.
Qualifications:
- Masters degree in statistics biostatistics mathematics or related field with 10 years experience preferring at least 12 years of clinical trial experience as a statistician
- Previous experience that provides the knowledge skills and abilities to perform the job
- 5 years of management responsibility
Strong leadership skills
Knowledge Skills and Abilities:
- Capable of effectively mentoring senior staff/managers to direct and promote teamwork in a multi-disciplinary team setting
- Superior management skills as shown through management of multiple projects and proven ability to manage mentor and motivate staff
- Demonstrated initiative and motivation
- Superior written and verbal communications skills including proficiency in the English language
- Positive attitude and the ability to work well with others
- Capable of supervising evaluating and mentoring departmental personnel
- Capable of delegating tasks and facilitating the completion of assignments
- Capable of driving innovation in developing new ideas related to process improvements
- Comprehensive organizational judgment analytical decision-making and interpersonal skills
- Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables Management Role:
- Directs through lower management levels. Has responsibility for managing a function that includes multiple related some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.
Required Experience:
Director
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more