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 consisting 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 s
Location: Mt Pleasant, PA
Posted: Oct. 2, 2024, 6:54 a.m.
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