Biostatistician II

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD's ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD's support services are strategically aligned with the program's mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD's collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program's mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides mathematical biostatistical support to the National Institute of Allergy and Infectious Diseases' (NIAID) Biostatistics Research Branch (BRB) within the Division of Clinical Research (DCR).

KEY ROLES/RESPONSIBILITIES

• Manages and/or leads delivery of statistical analyses and reporting services per timelines and project specifications
• Provides statistical support and mentorship to NIAID investigators, special projects, and emerging infectious disease research efforts
• Performs statistical analyses on data related to research, experimentation, diagnosis, treatment, prevention and cure of human disease
• Performs programming and statistical analysis on a broad range of clinical and laboratory studies and creates analysis data sets for assigned projects
• Consults with investigators on design and analysis of clinical and observational studies using knowledge of statistical methods
• Identifies appropriate methods to be used for processing and analyzing data that varies from project to project
• Preserves strong relationships with investigators through open, efficient and timely communications
• Maintains expertise in state-of-the-art data manipulation and statistical analyses
• Performs the programming, testing, and documentation of programs for use in creating statistical tables, listing and figures summaries
• Reviews case report forms and database setup with investigators, ensuring that the primary, secondary and any safety analysis can be performed per protocol
• Performs database management support by merging data from single or multiple sources to produce analysis data sets for assigned projects
• Detects data anomalies and provides feedback to project and data management teams (e.g., reviews tables/listings, edit checks output and statistical programs to ensure quality of deliverable)
• Assures the system and program documentation for assigned projects is complete and accurate
• Assists with development of clinical statistical training and mentorship programs as well as presents at training events and workshops
• Reviews and develops statistical analysis standardized operating procedures and best practice guidelines
• Conducts simulations to evaluate statistical methods
• Travels domestically and internationally as needed up to 10%
• This position is located in Rockville, Maryland

BASIC QUALIFICATIONS

• Possession of a Bachelor's degree with laboratory courses in a related discipline from an accredited college or university according to the Council for Higher Education Accreditation. (Additional qualifying experience may be substituted for the required education)
• Foreign degrees must be evaluated for U.S. equivalency
• A minimum of two (2) years of related experience
• Expertise in statistical methodology, software languages and computer systems
• Ability to work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
• Exercises judgment within defined procedures and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Ability to develop and implement problem solving techniques
• Strong communication skills with the ability to interact with people from diverse areas and disciplines
• Knowledge of scientific terminology used in the biopharmaceutical/clinical environment
• Must have a detailed understanding of automatic data processing, various department specific applications, and the Statistical Analysis System (SAS) or R
• Working knowledge of general principles related to statistics and data management analysis
• Must be able to obtain and maintain a Public Trust Clearance

PREFERRED QUALIFICATIONS

• Master's degree
• Knowledge of computing applications such as SAS/STAT and R

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

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