AD Biostatistics

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose: 
Manages a team of senior staff and/or managers within the department who are responsible for all statistical aspects of clinical trials. Acts as the senior reviewer or project oversight on multiple projects. Implements strategies to ensure overall project success. Aids in business acquisition activities, as needed.
 

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 projects, 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.
• Reviews departmental Working Practice Documents and contributes to changes as needed.
• Ensures department senior leadership is informed of team activities, 
accomplishments, and needs.
• Manages resource planning and utilization rate for the team. Ensures that 
appropriate personnel resources are applied to department projects based on 
priorities and relative complexity.
• Liaises with other departments within the company and the client.
• Participates in divisional decision making, bid preparation, and marketing 
activities.
• Provides statistical consultation and serves as senior statistical reviewer on 
projects.
• Reviews and/or approves documents related to project activities.
• Oversees the development and production of all projects, including large projects and NDA submissions

Qualifications: 
Education and Experience: 
Masters degree in statistics, biostatistics, mathematics or related field with 8+ years experience, preferring at least 10 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 and proven leadership skills.

Knowledge, Skills and Abilities: 
• Capable of effectively mentoring senior staff/managers to direct and promote teamwork in a multidisciplinary team setting
• Excellent management skills, as shown through management of multiple projects and proven ability 
to manage, mentor, and motivate staff
• Demonstrated initiative and motivation
• Excellent 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 and capable of independently assessing.

Working Conditions and Environment: 
• Work is performed in an office environment with exposure to electrical office equipment
• Domestic travel required occasionally; international travel required rarely and will be determined by 
client/department needs
• Constant interactions with associates and clients required
• Exposure to high pressure deadlines
• Intense concentration required
• When necessary, work additional hours to meet timelines
• Exposure to and use of electrical equipment required constantly
 

Physical Requirements:
• Frequently stationary for 6-8 hours per day. 
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. 
• Moderate mobility required. 
• Occasional crouching, stooping, bending and twisting of upper body and neck. 
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. 
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others, relates sensitive information to diverse groups both internally & externally. 
• Ability to apply abstract principles to solve complex conceptual issues. Requires multiple periods of intense concentration.
• Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. 
• Regular and consistent attendance.