About this role
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.