This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter (OTC) and prescription drugs, including biological therapeutics and generic drugs.
The Office of Biostatistics (OB) provides CDER and other internal and external stakeholders with statistical leadership, expertise, and advice to foster the expeditious development of safe and effective drugs and therapeutic biologics for the American people. OB’s mission is to protect the public health by applying statistical approaches for monitoring the effectiveness and safety of marketed drugs and therapeutic biologic products.
OB is recognized for excellence in the application and communication of statistical science in drug regulation and development. This office plays a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle.
This position is located in CDER, Office of Translational Sciences (OTS), Office of Biostatistics. As the primary advisor to the Office Director, the incumbent exercises a high degree of statistical expertise in fulfilling the duties and responsibilities of the position. The Deputy Office Director shares fully with the Office Director in all responsibilities pertaining to planning, managing, and directing the work of the Office. This involves providing both administrative direction and scientific guidance to subordinate supervisors/team leaders within the component Office who in turn directs the regulatory activities of highly trained and skilled staff of scientific professionals. Planning, assigning, reviewing, and evaluating the work and performance of applicable supervisor and employees.
As a Supervisory Mathematical Statistician, the incumbent participates fully in the day-to-day operations of the Office and in the absence of the Director. The incumbent will act with full authority for all areas of responsibilities to the Office Director in carrying out the variety of scientific, technical and administrative duties required of the position. This entails an understanding of all projects underway as well as an intimate understanding of major policy matters.
Assists in managing an Office. Reviews the implementation of new laws and regulations that impact the mission of the Office. This includes responsibility for the initiation and implementation of new policies, systems, procedures, and organizational structure.
Participates fully in the overall management of the Office with emphasis on statistical matters and administration. Possesses knowledge of administrative program management principles and skills to carry out the mission, as well as addressing and solving unusual and often precedent setting problems associated with the Office regulatory review program segment(s). Initiates decision making processes and documents; and participates fully in discussions and decisions concerning other Office plans, programs, and activities, both in strategic planning and in the actual determination, allocation, and administration of the Office program segment(s), functions and activities. Provides authoritative advice and assessment of the impact of actual and proposed Administration or Congressional actions on the program segment(s), functions, and activities.
Participates fully in planning, managing, organizing and directing all the operations, program segment(s), functions and activities of the Office including the formulation and establishment of the Office policies and goals, determination of organizational staff, and budget requirements, preparation of the budget, and allocation of Office resources necessary to accomplish the regulatory review mission of the Office.
Directs, oversees and coordinates the work of subordinate supervisors and/or team leaders; deals with high level officials and other organizations both within and outside the Agency; assures reasonable equity of performance standards and rating techniques developed by subordinate supervisors and/or team leaders. Recommends awards and bonuses for employees and changes in position classification; finds and implements ways to eliminate and reduce significant bottlenecks and barriers to production and promotes team building. Counsels and rates immediate subordinates.
Provides direct administrative and technical supervision to a group of employees including scientific, professional, technical, administrative and clerical support personnel assigned to the Divisions, ranging in levels from senior executive services to entry levels. Performs administrative and human resource management functions relative to the staff, including developing staffing plans and position descriptions, and identifying employee competencies necessary to meet organizational capabilities goals. Tracks recruitment and renewals and oversees interviews and selection recommendations.
Candidates must meet the education requirements in a scientific discipline and in the Mathematical Statistician 1529 series that is directly related to the position being filled and in accordance with the Office of Personnel Management (OPM) qualification standards. At a minimum, the candidate must possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral degree widely recognized in the U.S. academe as equivalent to a Ph.D. The ideal candidate should possess a doctoral-level degree (Ph.D., M.D., Pharm.D.) in biostatistics or statistics/epidemiology.
Professional Experience/Desirable Qualifications
Stature in the professional statistical community
A commitment to the highest standard of public service
A commitment for professional growth, development, and mentoring of scientific staff
A commitment to outreach and collaboration with internal and external stakeholders
A robust scientific background in translational sciences with a strong fundamental understanding of biostatistics and clinical medicine/therapeutics, and experience and/or knowledge of quality systems as they apply to the life cycle of drug development
Ability to function within a regulatory environment and problem solve to meet challenging demands
An understanding of Federal Regulations related to the work of the Center for Drug Evaluation and Research
Proven ability to provide strong leadership and promote maximum potential of a large organization with a multicultural workface
Prior senior leadership experience and excellent interpersonal skills
Telecommuting is allowed.
Internal Number: AD-1529-F
About Office of Biostatistics | Office of Translational Sciences | U.S. Food and Drug Administration
The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
Under the Center for Drug Evaluation and Research (CDER), Office of Translational Sciences (OTS), the Office of Biostatistics (OB) is recognized for excellence in the application and communication of statistical science in drug regulation and development. We play a central role in promoting innovative, science-based, quantitative decision-making throughout the drug development life-cycle. To support CDER’s mission, we provide statistical leadership, expertise, and advice to ensure that safe and effective drugs are available to the American people.