Manages a team within the department who are responsible for the statistical aspects of clinical trials from design through analysis and reporting including client or regulatory interactions.
Able to act as the lead statistician, project lead, senior reviewer or project oversight on select projects.
Contributes to study proposals and bids representing the department at bid defenses.
Organizes teams and implements strategies to ensure smooth operation and project financial success.
Coaches staff to provide effective oversight for strategic client relationships and/or oversight for significant client portfolios.
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.
Ensures the effective resource and utilization management of staff.
May act as lead statistician, project lead, senior reviewer or project oversight on multiple projects, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation.
May serve as the randomization statistician on selected projects.
Produces sample size calculations.
Provides input into study design and statistical considerations during protocol development.
Reviews protocols for completeness, appropriateness of clinical design and sound statistical analysis.
Contributes to writing appropriate protocol sections.
Supports and coaches staff to prepare and review statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required.
Contributes statistical methods section for integrated clinical statistical reports.
Reviews integrated clinical statistical reports.
Coaches staff to effectively communicate with sponsors concerning project work scope and budgetary changes after reviewing with management.
Aids departmental management in process improvement strategies.
Suggests, assesses and provides leadership in the department for such initiatives.
Conducts training and implementation of new procedures and new industry knowledge.
Supports strategic client franchise leadership.
Qualifications
Masters degree in statistics, biostatistics, mathematics or related field with 7 years experience preferring at least 8 years of clinical trial experience as a statistician.
Previous experience that provides the knowledge, skills and abilities to perform the job.
2 yrs of management responsibility.
Demonstrated initiative and motivation.
Capable of leading complex projects.
Effective management skills as shown through the successful management of multiple projects and staff members and proven ability to mentor and motivate staff.
Strong verbal and written communication skills including proficiency in the English language.
Positive attitude and the ability to proactively direct and promote teamwork in a multidisciplinary team setting.
In-depth knowledge of SAS and clinical biostatistics.
In-depth understanding of the drug development process and FDA regulations.
Capable of managing change and uncertainty to optimize positive outcomes.
Additional Responsibilities
Interprets and administers policies, processes and procedures that may affect sections and subordinate work units.
Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
Requires full knowledge of own area of functional responsibility.
Manager role with significantly larger management scope e.g. global or regional responsibilities or multiple departments OR mastery of manager skills and responsibilities as demonstrated by consistent multi-year successful performance.
In some instances may be responsible for a functional area as determined by executive management and not have subordinate supervisors or employees.
Assignments are defined in terms of activities and objectives.
Work is reviewed upon completion for meeting timelines, adequacy and objectives.
Interacts frequently with internal personnel and outside representatives at various levels.
Participates and may present at meetings with internal and external representatives.
Interaction typically concerns resolution of operational and scheduling issues concerning projects and/or contractual clarifications.
Work 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.
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.
Occasional 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 moderately 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.
Ability to apply basic principles to solve conceptual issues.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
