Fort Detrick, MD
About the Job:
The primary function of this biostatistics support role is data management and statistical regulatory oversight of non-clinical and clinical regulatory trials. Statistical regulatory oversight is defined as "ensuring that all statistical regulatory requirements as defined by FDA, ICH and other Health Authorities are complied with".
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
Will adhere to USAMMDA Biostatistics internal procedures for statistical regulatory oversight. The USAMMDA biostatistics team is responsible for statistical regulatory oversight of any organization (internal to DoD or external to DoD) that is providing full biostatistics support for an Office of the Surgeon General (OTSG) sponsored trial on behalf of USAMMDA or other DoD organizations.
Shall assist the Chief of Biostatistics at USAMMDA, in providing statistical regulatory oversight support and technical assistance to the Tech Based Programs and advance development vaccine/drug/device programs of MRMC.
Adhere to USAMMDA Biostatistics SOPs and internal procedures, FDA Guidance's, ICH documents, and if applicable, the external regulatory sponsor's SOPs/ SSPs. The Candidate shall attend the IPT and working group meetings (either on-site or via TCON, as determined by USAMMDA) in support of the Chief of Biostatistics.
Provide assistance with quality control and versions for Biostatistics and Statistical Analysis System (SAS) programming SOP's.
Provide advice and consultation support to the IPT and working groups, and communicate with the Chief of Biostatistics in regards to key issues that arise.
Assist the Chief of Biostatistics in implementing infrastructure for the discipline of biostatistics and statistical programming for FDA regulated clinical studies in human subjects.
Assist the Chief of Biostatistics with quality assurance/validation for the branch.
Assist the Tech Based Programs and advance development vaccine/drug/device programs (as needed and when applicable) with the development of the position papers, statistical analysis plans, the mock tables, listings, and figures, the interim analysis plans, statistical programming validation plans, technical issues associated with DSMB reports, technical issues associated with data analysis, and technical issues associated with FDA data deliverables.
Assist the USAMMDA medical writers (or the external regulatory sponsor's medical writers) with statistical issues associated with preparation of the Clinical Study Report and other documents to be submitted to the FDA. The Candidate shall assist the Tech Based Programs and advance development vaccine/drug/device programs (as needed and when applicable) with the statistical analyses for the FDA Annual Report and assist the USAMMDA medical writers (or the external regulatory sponsor's medical writers) with statistical issues associated with preparation of the FDA Annual Report (as needed).
Assist the USAMMDA regulatory scientists and the USAMMDA medical writers with statistical issues associated with FDA communications and FDA briefing documents (as needed). The Candidate shall assist the Chief of Biostatistics by attending FDA meetings and conference calls, including but not limited to, preparation of agendas and minutes (as needed).
Assist the Chief of Biostatistics with other biostatistical tasks as requested.
Skills & Knowledge:
Knowledge of biostatistics and the ability to develop correspondence and various documents in compliance with SOPs, using correct grammar, punctuation, and spelling. Education and training on clinical biostatistics and statistical programming, SOPs, templates, and forms.
Candidates for positions under ICON Government and Public Health Solutions contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
The McConnell Group (TMG) is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status or other status protected by law. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.