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US: Biostatistician

Date: 04-Dec-2012
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Collaborate with program staff on the implementation and analysis of Biostatistics aspects of research protocols. Provide statistical consultation for clinical programs, including but not limited to protocol development, randomization, sample size assessments, efficacy evaluations, and data review. CDPS Development: * Participate in the design of electronic case report forms (eCRFs) and corresponding edit checks to ensure that protocol objectives are met and project standards are maintained. * Develop clinical data file (CDF) specifications, and specifications for any other data transfers * Write CDF test data specifications, and coordinate the data entry effort. * Coordinate with SAS programming staff to ensure the accurate programming of CDF extracts and data displays. Statistical analyses, summaries and reports: * Develop statistical analysis summary and analysis plans. * Develop programming specifications to summarize the results of clinical trials. * Perform statistical analyses. * Provide tabular and written summaries of analyses and statistical methodology for Clinical Study Reports. * Provide content expertise and writing selected sections of project final reports. * For other Biostatisticians, provide independent statistical review of analysis plans, methodologies, and statistical summaries. Data Review: For those studies where contracted, perform ongoing aggregate-level review of data, to identify trends and areas of concern for data quality InfoLink, site payment system, and other global reporting development: * Participate with appropriate staff in assessing reporting needs. * Develop report and programming specifications, and coordinate programming and testing. * Write or coordinate development of test data specifications, and coordinate data entry effort. May oversee multiple protocol programs. Provide leadership, mentoring and statistical support for departmental staff. Assist the Director in defining and maintaining departmental standards, SOPs and working practices. May make presentations to clients and other interested individuals about the processes and procedures of the Clinical Reporting department. Perform other duties as assigned.

Knowledge of the biostatistical, programming, and data management aspects of the clinical research service industry. Understanding of GCP, ICH, and FDA guidelines and regulations applicable to conduct clinical research. Experience with the management and statistical analysis of data obtained from Phase I IV clinical trials. Ability to synthesize results in graphic, oral, and written reports. Experience using SAS (including data manipulation) and other software packages such as SPSS, S-Plus. Ability to plan long-range needs while assuming responsibility for daily details with a high degree of accuracy. Ability to work effectively and cooperatively with other professional staff members. Ability to communicate effectively, both verbally and in writing, with all levels of staff and with the public is required Excellent organizational skills, highly detail-oriented. Willingness to learn new programming languages, new technology, and new tools that will facilitate the clinical trial process. MS in Mathematics or Biostatistics with six years related experience; or doctorate-level degree in Statistics or Biostatistics with three years related experience. Data handling or analysis experience required. Excellent interpersonal and organization skills.

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