Scientific Data Analyst/Biostatistician

Scientific Data Analyst/Biostatistician

Job ID: req4040
Employee Type: exempt full-time
Division: Vaccine, Immunity and Cancer
Facility: Frederick: ATRF
Location: 8560 Progress Dr, Frederick, MD 21701 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.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

PROGRAM DESCRIPTION

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.

The Vaccine, Immunity, and Cancer Directorate (VICD) at the Frederick National Laboratory has a primary mission to provide scientific leadership and laboratory infrastructure to study immune responses to Human Papillomavirus (HPV) vaccines, other cancer preventive strategies and SARS-CoV-2 in the context of clinical and pre-clinical studies.

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. 

The Biomedical Data Analyst will be responsible for working directly with the HPV Serology Laboratory to manage large datasets and conduct data analyses of immunological data, including serology assay data, flow cytometry and other data generated by the laboratory in support of large clinical and epidemiological studies. The incumbent will work closely with the Scientific Manager and laboratory staff to provide statistical analysis, data trending, power calculations and study design. This is an onsite work position. No telework option.

The Scientific Data Analyst will:

• Build and manage databases.
• Perform review of lab data and associated documentation.
• Perform validations of templates used for data acquisition and analysis following pre-defined procedures.
• Perform complex data analyses, data QC, and data interpretation in a timely manner within projected timelines.
• Automate data collection and analysis processes.
• Prepare manual of procedures for data collection and data analyses.
• Analyze large amounts of data to identify biomarker measurement trends and patterns employing new and existing tools to interpret, analyze, and visualize data.
• Provide study design guidance to study investigators, such as power calculations and determine most appropriate statistical methods.
• Identify appropriate statistical methodology needed to meet study objectives.
• Perform statistical analyses of large, complex datasets from clinical trials and large epidemiological and longitudinal studies using appropriate statistical software packages.
• Design and generate tables and graphs in publication-quality form, and present results to managers and directors in a regular basis.
• Create databases and reports, develop algorithms and statistical models, and perform statistical analyses appropriate to data and reporting requirements.
• Prepare and deliver reports for interim and final analyses, including data sections for quality control and validation reports.
• Write and review statistical sections of study protocols, and manuscripts.
• Review study proposals, including clinical trials and apply standards to create summary data reports.
• Efficiently troubleshoot or report any unexpected technical problems.
• Effectively communicate with all data generators and submitters to address requests, questions and concerns and clearly document actions taken.

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

• Possession of Bachelor’s degree in Mathematics or Public Health or related degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) 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 experience in data analyses.
• Strong knowledge of statistics and scientific data analyses.
• Experience working with databases containing large data sets.
• Statistical programming languages such as R Script and SAS, applied to biomedical studies.
• Experience in evaluation of assay performance by applying appropriate statistical trend analysis.
• Strong analytical skills.
• Experience with data management, Lab Information Management Systems and data transfer from different platforms.
• Ability to obtain and maintain a security clearance.

Candidates with these desired skills will be given preferential consideration:

• A Masters degree in a quantitative science is preferred.
• Deep understanding and experience in processing high throughput biomedical data: data cleaning, normalization, analysis, interpretation and visualization.
• Ability to understand and analyze data from complex experimental and epidemiological designs involving immunology, serology and biomarker assay data.
• Proficiency in programming languages.
• Experience in assay development, reference standard data analyses.
• Experience in data standardization.
• Experience with GxP compliance.

• This position is subject to working with or have potential for exposure to infectious material, requiring medical clearance and immunizations.

Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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