Location: Madison, WI
Frontier Science Foundation is a clinical data management and statistical center with three office locations in the United States. Our office in Madison, WI is looking for a Biostatistician to join their dynamic team. 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, and to provide statistical support for regulatory submission work which supports pharmaceutical partners with drug license applications.
Major duties and responsibilities:
- As a statistician in support of IDMCs, 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
- Serve as clinical trial protocol statistician, while working closely with senior statisticians and clinical trial teams in the design, publication, and monitoring of clinical trials, as well as the analysis and publication of results from clinical trials and observations studies
- Participate in peer review, along with critique of reports and analyses from studies conducted by colleagues
- Conduct ongoing, periodic, and final analyses of data, using specialized statistical techniques and statistical programming
- Determine proper summary statistics, report formats, and address all other analysis considerations
- Review the proposed study methodology, study parameters, and related study features of proposals and protocols, to ensure conformance with accepted statistical principles
- Participate in regulatory submission work for clinical studies, with responsibility for analysis implementation plans (AIMs), output mock-up, programs to create ADaM datasets and TFLs, along with relevant documentations (ADRG, P21, define.xml etc. when appropriate)
- M.S. in Statistics/Biostatistics or equivalent
- Familiarity with clinical trials
- Familiarity with SAS, R, and LaTeX processes involved in report production
This position will be based out of Madison, WI, but consideration will be made for a full time remote worker.
Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center. A cover letter must be submitted to be considered for this position.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.