Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Office
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.