Regulatory Biostatistician

Regulatory Biostatistician Alaka`ina Foundation Family of Companies (FOCs) has a need for a Regulatory Biostatistician to 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 recommendatVisit the Employer site for more details