Biostatistician III

PROGRAM DESCRIPTION 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) Office of Biostatistics Research (OBR) Biostatistics Research Branch (BRB). 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 Supports development of novel statistical methodologies and analytical approaches, including novel Bayesian statistical methods for the analysis of high-dimensional, multi-modal biomedical data, including genomics, transcriptomics, and immunologic assays Designs and implements scalable inference algorithms (e.g., variational inference, Markov Chain Monte Carlo simulations, expectation propagation) to support large-scale infectious disease and immunology studies Supports methodological research on latent structure discovery, dimension reduction, and multi-study/multi-view data integration to identify biological mechanisms and disease signatures Provides statistical input in the design and analysis of studies involving complex exposures, longitudinal data, and heterogeneous data sources Advises investigators on statistical methodologies and best practices for analyzing high-dimensional and integrative datasets Conducts and validates complex power calculations either theoretically or by simulation Conducts simulations to evaluate statistical methods Preserves strong relationships with investigators through open, efficient and timely communications Maintains expertise in state-of-the-art data manipulation and statistical analysis 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 Travels domestically and internationally up to 10% including attendance at professional development opportunities or scientific symposia This position is located in Rockville, Maryland. Remote or hybrid work may be possible. BASIC QUALIFICATIONS To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: Possession of a Masters degree in Statistics, Biostatistics, Public Health, or related field with a minimum of five (5) years of experience OR PhD in a related field with a minimum of three (3) years of experience. Foreign degrees must be evaluated for U.S. equivalency Expertise in statistical modeling, study design, and data analysis 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 Detailed understanding of automatic data processing, various department specific applications, and the Statistical Analysis System (SAS) or R Demonstrates record of methodological research and publication Experience developing statistical software or contributing to open-source tools Expertise in Bayesian statistics and high-dimensional inference, including hierarchical modeling and latent variable methods Experience in developing or applying computationally efficient algorithms for complex models (e.g., variational methods, Markov Chain Monte Carlo simulations, or related approaches) Ability to analyze and integrate multi-source or multi-omics datasets in biomedical, environmental, or related scientific domains Experience supervising statisticians and statistical programmers Working knowledge of general principles related to statistics and data management analysis Ability to obtain and maintain a security clearance