200+ applicants

Company

Alaka`ina Foundation Family of Companies · 4 days ago

Biostatistician

United States

Full-time

Remote

Senior Level

7+ years exp

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No H1B

U.S. Citizen Only

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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.

Qualification

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BiostatisticsStatistical AnalysisSAS SoftwareClinical Study DesignStatistical ProgrammingFDA RegulationsLaboratory Practice (GLP)Clinical Practice (GCP)Statistical ValidationData ManagementStatistical Analysis Plan (SAP)Sample Size CalculationStatistical Reporting

Required

Master's degree or educational equivalent in statistics or related field.

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.

Must have or be able to obtain a NACI (Tier 1 Investigation)

Must be a U.S. Citizen