Biostatistician

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FACTOR I KNOWLEDGE REQUIRED BY THE POSITION.

This position requires a professional knowledge of the theories, principles, methods, and techniques of statistics, especially to those applicable in the research area of cooperative clinical trials. A Ph.D. in statistics or epidemiology or a Masters in statistics with appropriate experience are desirable. It also requires a professional knowledge of commonly used statistical software packages such as SAS, BMDP, Systat, NQUERY, and SPSS. The incumbent draws on this broad knowledge of and experience in health science and clinical investigation, biostatistics and data processing, and applies this knowledge and experience along with appropriate management techniques to study protocol development, data coordination, data processing, data analysis and report writing, as well as coordination of all study meetings and other administrative functions related to conducting cooperative clinical studies within the Department of Veterans Affairs or other government agencies as appropriate.

MAJOR DUTIES

The primary responsibility of this position is to provide for the complete management of assigned cooperative (multi-center) clinical trials funded or otherwise authorized through the Cooperative Studies Program (CSP) and coordinated through the CSP Coordinating Center (CSPCC) at VAMC Perry Point. This management role extends for the duration of a study from its inception until the final archiving of data and involves management and coordination of administrative activities (within the CSPCC, his/her assigned studies, and CSP, VACO), planning meetings, protocol writing and submission, data processing, statistical analysis, report writing and any additional ancillary activities as required.
A secondary responsibility of this position is to serve as a faculty member in the University of Maryland Department of Epidemiology and Preventive Medicine, providing clinical trials methodologic expertise to the graduate programs and research projects at the University.

Specific duties of the position are as follows:

• Serves within the CSPCC as manager of a study team that consists of database management personnel, a member(s) of the statistical programming section and a project manager. Conducts team meetings, assigning study tasks, and reviews team output to ensure that assigned studies are conducted according to guidelines and completed in a timely fashion.
• Serves as full scientific member of study Planning Committees and study Executive Committees with final responsibility for scientific and biostatistical aspects of study design. Assists the study proponent in the selection of a study planning committee and, with the support of the CSPCC administrative section, develops a schedule for planning a study.
• Collaborates with the study planning committee to develop a cooperative study protocol that assures the collection of complete, accurate, unbiased and clinically/scientifically relevant data suitable for statistical analysis and data processing and that is suitable for submission to the Cooperative Studies Evaluation Committee. A final protocol will include a study budget, completely developed study forms and a plan for biostatistical analysis and data processing. In addition, he/she and the Study Chairman present and defend the protocol before the Cooperative Studies Evaluation Committee.
• Collaborates with the Study Chairman in selection of participating study centers and assures that administrative requirements are met so that startup proceeds according to a timely schedule.
• Assists the Study Chairman in identifying appropriate nominations for study Executive Committees and Data and Safety Monitoring Boards.
• Designs, with the Study Chairman and the data management section, a study data editing system with a detailed editing manual that will assure the availability of an accurate study database. Is responsible for reviewing the data editing system and verifying its accuracy.
• Designs, with the assistance of a statistical programmer, both the content and format of all study interim statistical reports for Study Groups, Executive Committees, and Data and Safety Monitoring/Human Rights Committees. Is responsible for checking the accuracy of programs used in the reports and for reviewing reports for accuracy prior to distribution to the Committees.
• Works with study team to develop study operations manuals.
• Organizes, with the assistance of the Study Chairman and the CSPCC administrative section, all study meetings including travel arrangements and distribution of meeting materials including interim reports and other data summaries.
• Develops, during the ongoing phase of a study, special study progress reports for review of the Cooperative Studies Evaluation Committee at intervals of three years and appears before that committee along with the Study Chairman.
• Performs and presents final analyses at the completion of a study in a final report and collaborates with the study Executive Committee in the interpretation of study results, the preparation and publication of reports in the appropriate scientific journals, and the presentation of results at professional meetings. Assists other investigators with secondary analyses. Writes and/or participates in writing study and methodological manuscripts for publication.
• Develops plans for the archiving of study databases and correspondence files at the conclusion of a study.
• Maintains a comprehensive surveillance of the statistical literature with particular attention to promising new approaches to analysis that may be of direct benefit in immediate application to studies in the CSPCC.
• Maintains a program of independent methodologic research in clinical trial/biostatistical methodology and applications.

FACTOR VII PURPOSE OF CONTACTS

The purpose of contacts within the CSPCC is to assure that study meetings are arranged and that materials including study correspondence, reports, and other documentation are completed; assure that statistical reports and analyses are completed; and assure that the database system is completed as required and in a timely way. Contacts outside the CSPCC are necessary to facilitate the smooth administrative management of the study during all its phases; to provide for day-to-day scientific management of studies and to provide authorized review and oversite committees with personal briefing and written reports of study progress; and, to participate in a collegial way in the scientific life of the statistical and medical professions.