Frederick National Laboratory Job - 39256519 | CareerArc
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Company: Frederick National Laboratory
Location: Rockville, MD
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Biostatistician I/II

Job ID: req1846
Employee Type: exempt full-time
Facility: Rockville: Fishers Ln
Location: 5601 Fishers Ln, Rockville, MD 20852 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Our core values of accountability, compassion, collaboration, dedication, integrity, and versatility serve as a guidepost for how we do our work every day in serving the public's interest.  

 Position Overview:

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH.  CMRPD's ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD's support services are aligned with the program's mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD's collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD'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). Major research areas include infectious diseases (e.g., COVID, HIV, influenza, tuberculosis, malaria, Zika, Ebola), allergy and immunology.

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

This position may be filled with a Biostatistician I or Biostatistician II commensurate with the selected candidates experience

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Biostatistician I:

  • 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 or six (6) years relevant experience in lieu of degree.  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
  • Understanding of clinical trials and the drug development process
  • 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 the biopharmaceutical/clinical environment
  • Detailed understanding of automatic data processing, including R
  • Knowledge of general principles related to 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
  • Ability to obtain and maintain a security clearance

Biostatistician II:

  • 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 or six (6) years relevant experience in lieu of degree.  Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of progressively responsible experience
  • Must have 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
  • 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
  • Ability to obtain and maintain a security clearance

 PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • 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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