Statistics in Biopharmaceutical Research

Statistics in Biopharmaceutical Research ( SBR), publishes articles that focus on the needs of researchers and applied statisticians in biopharmaceutical industries; academic biostatisticians from schools of medicine, veterinary medicine, public health, and pharmacy; statisticians and quantitative analysts working in regulatory agencies (e.g., U.S. Food and Drug Administration and its counterpart in other countries); statisticians with an interest in adopting methodology presented in this journal to their own fields; and nonstatisticians with an interest in applying statistical methods to biopharmaceutical problems. Statistics in Biopharmaceutical Research accepts papers that discuss appropriate statistical methodology and information regarding the use of statistics in all phases of research, development, and practice in the pharmaceutical, biopharmaceutical, device, and diagnostics industries. Articles should focus on the development of novel statistical methods, novel applications of current methods, or the innovative application of statistical principles that can be used by statistical practitioners in these disciplines. Areas of application may include statistical methods for drug discovery, including papers that address issues of multiplicity, sequential trials, adaptive designs, etc.; preclinical and clinical studies; genomics and proteomics; bioassay; biomarkers and surrogate markers; models and analyses of drug history, including pharmacoeconomics, product life cycle, detection of adverse events in clinical studies, and postmarketing risk assessment; regulatory guidelines, including issues of standardization of terminology (e.g., CDISC), tolerance and specification limits related to pharmaceutical practice, and novel methods of drug approval; and detection of adverse events in clinical and toxicological studies. Tutorial articles also are welcome. Articles should include demonstrable evidence of the usefulness of this methodology (presumably by means of an application). The Editorial Board of SBR intends to ensure that the journal continually provides important, useful, and timely information. To accomplish this, the board strives to attract outstanding articles by seeing that each submission receives a careful, thorough, and prompt review. ASA Statement on Justice, Equity, Diversity, and Inclusion (JEDI) The leadership of the American Statistical Association commits to strengthening our professional community by making it more just, equitable, diverse, and inclusive. We affirm that our mission, Promote the Practice and Profession of Statistics, can be realized only by fully embracing justice, equity, diversity, and inclusivity in all of our operations. Individuals embody many traits, so the leadership will work with the members of ASA to create and sustain responsive, flourishing, and safe environments that support individual needs, stimulate intellectual growth, and promote professional advancement for all. We commit to these objectives: Learn from our members and others how to identify and overcome systemic racism and hindering biases of any kind Critically reappraise and improve the effectiveness of our JEDI efforts Identify and develop resources for individuals and organizations in our professional community to enable growth and appreciation for cultural humility Share openly our diversity and inclusion efforts and the solutions we have implemented