Biostatistician I

Location
Bldg 102, MD, USA
Posted
Oct 11, 2019
Ref
req591
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time
Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide 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), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD'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, CRD 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. CRD'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.

KEY ROLES/RSPONSIBILITIES

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

The position will support state-of-the-art research activities for the AIDS Imaging Research Section of NIAID and will be based in an imaging laboratory located in Poolesville, MD, with periodic visits to offices in Rockville, MD.

Specifically, the position will be involved in studies of in vivo imaging of HIV pathogenesis using Simian Immunodeficiency Virus (SIV) infected nonhuman primates and will work in an interdisciplinary research team of immunologists, imagers, radiochemists, veterinarians and mathematicians.

The successful candidate will receive training and assist in the following areas: Image analysis and mathematical modeling of imaging data, cell binding assays and in vitro kinetic studies, autoradiography, SPECT, PET and CT image acquisition, and monitoring vital signs of the animals during the imaging acquisition phases under the direction of NIH veterinary staff.
  • Performs mathematical and statistical analyses on data related to research, experimentation, diagnosis, treatment, prevention and cure of human disease
  • Performs programming and analysis on a broad range of clinical and laboratory studies and creates analysis data sets for assigned projects
  • 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 analyses
  • Performs programming, testing, and documentation
  • 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
  • Reviews and develops analysis standardized operating procedures and best practice guidelines
  • Conducts simulations to evaluate methods
  • Quantifies image analysis, data collection, and radiologic images to present at national and international meetings and publications in high impact peer-reviewed scientific journals
  • Integrates and coordinates efforts from team members
  • Maintains timelines for achievement of developmental goals
  • Assists in optimizing imaging workflows from scanner to workstation for interpretations
  • Assists with development/maintenance of comprehensive databases and metrics
  • Work location will be split between Poolesville, MD (80%) and Fisher's Lane in Rockville, MD (20%)

BASIC QUALIFICATIONS
  • Possession of a Master's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) with laboratory courses in a related discipline (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • No experience required beyond a Master's degree
  • Ability to work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors
  • Ability to exercise 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 a biopharmaceutical/clinical environment
  • Knowledge of general principles related to mathematics, statistics and data management analysis
  • Ability to learn and comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, Standard Operating Procedures (SOPs), and, when applicable, CDISC DASH, STDM and ADaM Standards
  • Must be available to work occasional evenings and late night or early morning sessions at either work location
  • Must be able to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS
  • Previous training or experience in working in nuclear medicine imaging studies or nonhuman primate infectious diseases studies

JOB HAZARDS
  • Candidate will be working with or have the potential for exposure to animal(s) and/or animal material(s)
  • Candidate is subject to atmospheric conditions that would require the use of a respirator, requiring a medical clearance
  • Candidate would be working with radioactive materials and requires them to become an approved radiation worker

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