Regulatory Biostatistician

Alaka`ina Foundation Family of Companies (FOCs) has a need for aRegulatory Biostatisticianto support our government customer located in Frederick, Maryland.

DESCRIPTION OF RESPONSIBILITIES:

Biostatistics provides biostatistical support to all research elements within USAMRIID, including clinical and non-clinical research projects. Biostatisticians work closely with study directors, Principal Investigators (PIs), and other key staff to design and perform statistical analyses, and product development strategies from the perspective of applicable FDA and animal care and use guidelines.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

MS in biostatistics, with 8 years of experience in performing clinical or pre-clinical statistical analysis. (As a substitute for the MS in biostatistics, a related MS degree with substantial (30+ hours) of statistics coursework would be acceptable.)
Examples of alternate majors which, combined with a concentration in statistics, would fulfill this requirement include Mathematics, Operations Research, Epidemiology, Public Health, or Behavioral Health and Sciences.

REQUIRED SKILLS AND EXPERIENCE:

• 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 shall 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, e.g., 21 CFR Part 58 and 21 CFR Part 11.
• 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 shall 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. Have strong written and verbal communication skills to be able to present and discuss experimental results at group/project team meetings and scientific conferences.
• Be able to work independently based on broad guidelines and objectives provided by the government point of contact as well as be able to work in a team structure and interface with different research and development departments.
• Collaborate with study directors, PIs, and other key staff to perform statistical analyses and provide statistical support for approximately 30 clinical and approximately 100 nonclinical protocols annually, 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. Work includes incorporating 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 (SAP), interpret analyses, and write the statistical section of the study report. Draft plans and specifications shall be provided to the government for approval, due at least 15 business days prior to data analysis. Ensure plans and execution of statistical functions meet all applicable regulations, guidance, and procedures.
• Collaborate with the government to determine acceptable procedures and formats for all deliverables provided, and shall ensure consistency and harmonization with USAMRIID processes.
• Provide recommendations, as applicable, to improve data cleaning, formatting, or statistical analysis processes. Collaborate with government representatives and other staff supporting USAMRIID and USAMRDC to develop and write standard operating procedures and other process documents.
• Provide to the government the final statistical analysis plans with table shells, due 30 business days from the receipt of data; a contributing scientist report summarizing the results of the analysis; a tables, listings, and figures (TLF) document accompanying the contributing scientist report, due 30 business days from the receipt of data and any data sets created during analysis. Collaborate with the government to determine appropriate and secure means for files transfer.
• Possess the ability to work independently with minimal government guidance and shall rely on extensive experience and judgment to plan and accomplish stated goals.
• Based on USAMRIID's current mission it will be necessary to provide surge biostatistical support in different areas throughout the period of performance of the task order. The current off-site surge requirement includes comprehensive biostatistical support for up to 10 GCP and 6 GLP studies per year. The surge support option may be exercised for any portion of a period of performance.

REQUIRED CITIZENSHIP AND CLEARANCE:

• Must be a U.S. Citizen
• Must have a Secret Clearance to start

The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries. Eligible employees enjoy a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays.

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not illegally discriminate in employment decisions on the basis of any protected categories. If you are a person with a disability and you need an accommodation during the application process, please clickhereto request accommodation. We E-Verify all employees

"EOE, including Disability/Vets" OR "Equal Opportunity Employer, including Disability/Veterans"

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, Kpono Government Services, and Kapili Services, Po`okela Solutions, Kkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

For additional information, please visit www.alakainafoundation.com

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