Director - Biostatistics

Work Schedule

Environmental Conditions

Job 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 departments. In 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.