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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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