Senior Manager, Biostatistics

Work Schedule

Environmental Conditions

Job Description

Senior Manager, Biostatistics

Job Description

• 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.
• Ability to perform under stress.
• Ability to multitask.
• Regular and consistent attendance.