Designing experiments & interpreting results
The Biostatistics Group plays a key role throughout the drug discovery and development process, particularly in the design of experiments and analysis and interpretation of results. From basic research to marketing approval and post-marketing surveillance, biostatisticians located in Blue Bell and West Point, PA, Rahway, NJ, and Brussels, Belgium support all of MRL's drug and vaccine development programs as key members of project teams.

Biostatisticians work with basic research scientists to design efficient screening experiments that accurately identify potential drug candidates with desired effects. Once an active drug candidate is identified, biostatisticians help scientists to design animal safety experiments towards the goal of minimizing the number of research animals required for the tests. In addition, biostatisticians work with process chemists and engineers to design and analyze experiments that yield the best production processes for making bulk drug. Other experiments are designed and analyzed to help formulate the compound into an appropriate dosage form.

After safety testing and process development, biostatisticians play an integral part in the clinical trial process, assisting clinical physicians in experimental strategy and study design, including selection and validation of study measurements and definition of subsequent statistical analyses. Biostatisticians also make presentations at scientific meetings and co-author research journal articles to summarize original statistical methodology and/or unique medical results. Our biostatisticians also meet with their counterparts in regulatory agencies to address questions during drug review.

After drug approval, the biostatistician's job is not over. Further testing may be necessary to address specific questions from regulatory agencies or for novel uses of the drug. Biostatisticians work with economists to document the drug's impact on costs in comparison to alternative treatments.

Biostatisticians are needed to support all phases of pharmaceutical research and development. If you have a Ph.D. or Masters in biostatistics or statistics, submit your resume to be considered for the excellent career opportunities available in MRL's Biostatistics Group.