The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Biostatistician to support our government customer in Silver Spring, Maryland. This position is remote.

The Biostatistician will provide solutions to the clients with questions in statistical methodology, statistical analysis, and statistical computing. Ensure the study design, data collection, and statistical analysis is appropriate to meet study objectives. Provide all documentations including study protocol, statistical analysis plan, statistical analysis system (SAS) programs, SAS programs specification, table, listing, figure for final study report to meet WRAIR and Food and Drug Administration (FDA) guidelines, to include clinical data interchange standards consortium (CDISC) formatting compliance. Ensure that a clinical protocol is both scientifically feasible and has scientific merit. Ensure that the number of animals used is appropriate to obtain sufficient data and/or is not excessive, and the statistical design is appropriate for the intent of the study.

Develop a Statistical Analysis Plan of a plan for each clinical trial and a monthly report on status of each trial’s statistical progress to include statistical validation that contain statistical programming specs and the statistical programs used to produce the tables, listings and figures (TLFs) as well as all ad hoc analyses and reports requested by the Sponsor and/or the FDA. Consider coding conventions and formats used in statistical programs. The plan shall include data populated TLFs (for the study clinical study report, the data monitoring committee, the FDA annual reports, and other sponsor/FDA statistical requests) and all required components for the submission of data to FDA in the FDA-required format. The document shall be in Clinical Data Interchange Standards Consortium (CDISC) format and shall include define.xml (define.pdf), Study Data Tabulation Model (SDTM), Analysis Data Model (AdaM), and the Reviewer’s Guide. The statistical programs used to create the CDISC data sets shall be provided along with the programming specs. The Standard for Exchange of Nonclinical Data (SEND) for all non-clinical data submission is required and shall be used for all communications and/or statistical products for sponsor requests/queries; all communications and/or statistical products for FDA requests/queries; statistical review of protocol; statistical review of clinical study report, biostatistics project management; and review of TLFs prior to database lock.

DESCRIPTION OF RESPONSIBILITIES:

Develop statistical methods sections of study plans and protocols, including sample size calculations, and shall review study case report forms for advanced animal studies to be conducted in compliance with FDA’s Good Laboratory Practice Regulation (GLP) and relevant sections of other FDA regulations, e.g., 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 deliverables and 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 as required. Collaborate with Study Directors, Principal Investigators, Study Coordinators, 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 USAMRDC 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, interpret analyses, and write the statistical section of the study report. Draft plans and specifications shall be provided to the Government for approval. 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 USAMRDC processes. Provide recommendations, as applicable, to improve data cleaning, formatting, or statistical analysis processes. Collaborate with government representatives and other staff supporting  USAMRDC to develop and write standard operating procedures and other process documents. Provide to the government the final statistical analysis plans with 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. Possess the ability to work independently with minimal government guidance and shall rely on experience and judgment to plan and accomplish stated goals. Based on USAMRDC 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 approximately 10 GCP and 6 GLP studies per year. The surge support option may be exercised for any portion of a period of performance. Other duties as assigned by Supervisor.

REQUIRED DEGREE/EDUCATION/CERTIFICATION:

Master's degree or educational equivalent in statistics or related field. (Preference will be given to candidates with an MS in statistics with at least 2 years’ experience supporting advanced phase clinical studies.)

REQUIRED SKILLS AND EXPERIENCE:

Seven plus (7+) years’ experience performing clinical or pre-clinical statistical analysis. Strong written and verbal communication skills to be able to present and discuss experimental results at group/project team meetings and scientific conferences. 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.

REQUIRED CITIZENSHIP AND CLEARANCE:

Must have or be able to obtain a NACI (Tier 1 Investigation) Must be a U.S. Citizen

 

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. We are proud to state that we do not discriminate in employment decisions based on race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click  to request accommodation. We E-Verify all employees.

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, Kūpono Government Services, and Kapili Services, Po`okela Solutions, Kīkaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

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