Location: Madison, WI
Purpose: The general role of the Biostatistician is to analyze interim data from ongoing clinical trials and prepare reports for independent Data and Safety Monitoring Committee (IDMC) review.
Major Duties and Responsibilities:
- Serve as lead statistician to create, test, document, and archive programs used for analyses; and in this capacity, work to maximize the clarity and completeness of the presentation of study results
- Become fully familiar with the study documents, including the protocol, case report forms, IDMC charter, and statistical analysis plan
- Presenting IDMC interim monitoring reports
- Drafting IDMC meeting minutes
- Drafting the report analysis plan for the interim monitoring reports
- Be aware of anticipated and emerging safety and efficacy issues in the studies and initiate analyses to address those issues in interim monitoring reports
- Schedule data transfers and communicate any problems with data transfer to the appropriate contacts
- Oversee the distribution of the interim monitoring reports and the accompanying materials (cover letter, agendas, report summary, minutes of previous meeting, etc.)
- Organize and maintain study directories containing electronic documents, data, report programs, and electronic copies of the monitoring reports
- Maintain an email folder with all informative email communication
- Serve as support statistician to create, test, document, and archive programs used for independent verification of analyses prepared by the lead statistician
- Attending professional meetings and short courses to expand or maintain professional knowledge and expertise, and participating in informal seminars and training sessions for the Madison office statisticians
- Engaging in educating him/herself in any areas of interim analysis in which his/her former experience and formal education were not sufficient.
- M.S. in Statistics/Biostatistics or equivalent
- 0-10 years of experience
- Familiarity with clinical trials
- Familiarity with SAS, R, and LaTeX processes involved in report production.
Please send a resume, cover letter, and three references to firstname.lastname@example.org. You may also send your resume, cover letter and three references to Carla Fears at Frontier Science - Madison, 440 Science Drive, Suite 401 Madison, WI 53711. Please visit our website at www.fstrf-isc.org.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.