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Vacancy details
Vacancy description:
Job Code:
15058
Job Title:
Director, Biostatistics
Job Category:
IT & Data Management
Contract:
Permanent
Discipline:
Statisticians, Director
Country:
United States Of America
Location:
North Carolina
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
06 Jul 2008
Director, Biostatistics
Wilmington, NC
Requirements
This position leads the operational activities of the Biostatistics Department. Evaluate workloads, resources, process, and technology for efficient operation of the department. Also, ensures systems are in place to produce quality work efficiently, allowing for continual growth of department and consults with project team, sponsor, and FDA on project-related issues.
This position contributes directly to revenue through performing statistical analyses and consultation on study protocols, marketing and generation of proposals, and supervising statistical staff.
SUPERVISORY RESPONSIBILITIES:
Direct supervisor of a department, section, unit or group involving responsibility for results in terms of cost, methods and personnel. Full accountability for hiring, discipline, discharge, performance appraisals, salary administration, etc.
PRIMARY ACCOUNTABILITIES:
.Responsible for leading, managing, and utilizing human resources for the department
.Promote all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan
.Assure department adherence to good scientific, ethical, and regulatory standards
.Assess department's adherence to Working Practice Documents and SOPs on an ongoing basis
.Facilitate changes as needed
.Responsible for keeping the Vice President and Executive Director informed of department activities, accomplishments, and needs
.Responsible for long-range strategic planning, development of departmental business plan, and departmental budget
.Responsible for preparing bids, for marketing, and business development
.Responsible for communicating company and department policies and priorities to department staff and assuring compliance
.Responsible for personnel management, including personnel recruitment, performance evaluation, promotion, and termination
.Responsible for ensuring that appropriate personnel resources are applied to department projects based on priorities and relative complexity
.Responsible for project budgets in terms of staff training, review, and overall accountability
.Provide statistical consultation and serve as senior reviewer on projects
.Review and/or approve documents related to project activities
.Oversee the development and production of all projects, including large projects and NDA submissions
.Participate in project development and FDA meetings concerning investigational and marketed drugs assigned to the department
EDUCATION AND EXPERIENCE:
.Minimum 6-10 years experience in clinical research and management
.Ph.D. or MA/MS in statistics, biostatistics, mathematics, or related field
-Strong professional interest in one or two specific clinical science areas of application (e.g., antiviral, respiratory medicine, endocrinology, cardiology, immunology, oncology, etc.)
.Active participation in one or two professional statistics organizations
KNOWLEDGE, SKILLS AND ABILITIES:
.Demonstrated understanding of CRO working relationships and business nature
.Ability to lead in a multi-disciplinary team setting
.Proven performance of required tasks, as evidenced by outstanding performance in current tasks and/or documented record of accomplishments
.Evidence of strong management skills, as shown through management of multiple projects and staff members
.Demonstrated initiative and motivation
.Excellent written and verbal communications skills
.Good organizational skills, with the ability to adapt and adjust to changing priorities
.Positive attitude and the ability to work well with others
.Evidence of initiating and developing streamlined process-improvement programs or products
.Expertise in one or more areas of specific statistical methodology such as categorical data analysis, generalized linear model, survival analysis, response surface modeling, health economics, or Phase I studies
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
.Constant exposure to and use of electrical equipment
PPD is an Equal Opportunity Employer
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Please Note: Applications to this vacancy are not made using our website. When you click above, you will be taken to the recruiter's website to complete your application.
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