To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Develop statistical models using clinical and biological data that will inform clinical trial design (e.g. overall design schema, sample size calculations, screening, randomization, inclusion/exclusion criteria, etc.) in support of the NPH PMO
- Design and implement adaptive and innovative clinical trial designs, including Bayesian approaches used in platform trial designs, using biomarkers, including those derived from positron emission tomography (PET) imaging, functional and structural magnetic resonance imaging (MRI), electroencephalogram (EEG), and genetics/genomics.
- Provide FDA regulatory biostatistical support to USAMRIID’s science and technology and medical countermeasure test and evaluation capabilities to facilitate approval of biomedical products by FDA.
- Develop statistical methods sections of study plans and protocols, including sample size calculations, and review study case report forms for advanced clinical and non-clinical studies to be conducted in compliance with FDA’s Good Laboratory Practice (GLP) regulation, Good Clinical Practice (GCP) regulation, and relevant sections of other FDA regulations, i.e. 21CFR and 11CFR.
- Advise data management staff on database design, validation checks, and critical data during the clinical/nonclinical database development process.
- Prepare and coordinate the development of analysis plans, table specifications and shells, write and perform programming of specifications for analysis files, consistency checks, tables, listings and figures.
- Perform data review and statistical analyses using SAS software.
- Communicate with clients regarding study protocol or statistical analysis issues as they arise, provide expert statistical advice on statistical deliverables, and communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.
- Interpret analyses and write statistical sections of study reports, including integrated reports as required.
- Demonstrate strong written and verbal communication skills to be able to present and discuss experimental results at group/project team meetings and scientific conferences.
- Work independently based on broad guidelines and objectives provided by the government point of contact, as well as working in a team structure to interface with different research and development departments.
- Demonstrate proficiency in biostatistics, to include support of clinical and non-clinical studies.
- Collaborate with Study Directors, Principal Investigators, Study Coordinators and other key staff to perform statistical analyses and provide statistical support for clinical and non-clinical protocols, and comply with the FDA GLP and GCP regulations when applicable.
- Develop biostatistical aspects of study designs, statistical analysis plans, statistical analyses, study reports, and other relevant documents and efforts. Provide consultative support on the statistical suitability and regulatory compliance of USAMRIID protocol designs, statistical plans and analyses, and product development strategies from the perspectives of applicable FDA and animal care and use regulations.
- Incorporate a variety of concepts, regulations, standards, practices, and procedures of the biostatistical and pharmaceutical/vaccine research and development field.
- Prepare analysis plans, and write detailed specifications for analysis files, consistency checks, tables, and figures.
- Complete analyses from raw data according to the protocol or Statistical Analysis Plan, interpret analyses, and write the statistical section of the study report. Draft plans and specifications for government approval. Ensure plans and execution of statistical functions meet all applicable regulations, guidance, and procedures.
- Collaborate with the government to determine that acceptable procedures and formats for all deliverables are provided, and ensure consistency and harmonization with USAMRIID processes as needed.
- Provide recommendations, as applicable, to improve data cleaning, formatting, or statistical analysis processes. Collaborate with government representatives and other staff supporting USAMRIID and USAMRMC to develop and write standard operating procedures and other process documents.
- Provide the government with final statistical analysis plans to include: table shells; a contributing scientist report summarizing the results of the analysis; a tables, listings, and figures (TLF) document accompanying the contributing scientist report; and any data sets created during analysis. Collaborate with the government to determine appropriate and secure means for files transfer.
- Work independently with minimal government guidance and rely on extensive experience and judgment to plan and accomplish stated goals.
- Ensure that monthly reports are submitted outlining the expenditures, billings, progress, status, hires/potential hires, and any problems/ issues encountered in the performance of this task using formats agreed upon by the Government and contractor.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.