In the statistical domain, certain topics have received considerable attention during the last decade or so, necessitated by the growth and evolution of data and theoretical challenges. This growth has invariably been accompanied by computational advancement, which has presented end users as well as researchers with the necessary opportunities to handle data and implement modelling solutions for statistical purposes. Showcasing the interplay among a variety of disciplines, this book offers pioneering theoretical and applied solutions to practice-oriented problems. As a carefully curated collection of prominent international thought leaders, it fosters collaboration between statisticians and biostatisticians and provides an array of thought processes and tools to its readers. The book thereby creates an understanding and appreciation of recent developments as well as an implementation of these contributions within the broader framework of both academia and industry. Computational and Methodological Statistics and Biostatistics is composed of three main themes: * Recent developments in theory and applications of statistical distributions;* Recent developments in supervised and unsupervised modelling;* Recent developments in biostatistics; and also features programming code and accompanying algorithms to enable readers to replicate and implement methodologies. Therefore, this monograph provides a concise point of reference for a variety of current trends and topics within the statistical domain. With interdisciplinary appeal, it will be useful to researchers, graduate students, and practitioners in statistics, biostatistics, clinical methodology, geology, data science, and actuarial science, amongst others.

This book is comprised of presentations delivered at the 5th Workshop on Biostatistics and Bioinformatics held in Atlanta on May 5-7, 2017. Featuring twenty-two selected papers from the workshop, this book showcases the most current advances in the field, presenting new methods, theories, and case applications at the frontiers of biostatistics, bioinformatics, and interdisciplinary areas. Biostatistics and bioinformatics have been playing a key role in statistics and other scientific research fields in recent years. The goal of the 5th Workshop on Biostatistics and Bioinformatics was to stimulate research, foster interaction among researchers in field, and offer opportunities for learning and facilitating research collaborations in the era of big data. The resulting volume offers timely insights for researchers, students, and industry practitioners.

This book examines statistical methods and models used in the fields of global health and epidemiology. It includes methods such as innovative probability sampling, data harmonization and encryption, and advanced descriptive, analytical and monitory methods. Program codes using R are included as well as real data examples. Contemporary global health and epidemiology involves a myriad of medical and health challenges, including inequality of treatment, the HIV/AIDS epidemic and its subsequent control, the flu, cancer, tobacco control, drug use, and environmental pollution. In addition to its vast scales and telescopic perspective; addressing global health concerns often involves examining resource-limited populations with large geographic, socioeconomic diversities. Therefore, advancing global health requires new epidemiological design, new data, and new methods for sampling, data processing, and statistical analysis. This book provides global health researchers with methods that will enable access to and utilization of existing data. Featuring contributions from both epidemiological and biostatistical scholars, this book is a practical resource for researchers, practitioners, and students in solving global health problems in research, education, training, and consultation.

This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

This book brings together the voices of leading experts in the frontiers of biostatistics, biomedicine, and the health sciences to discuss the statistical procedures, useful methods, and novel applications in biostatistics research. It also includes discussions of potential future directions of biomedicine and new statistical developments for health research, with the intent of stimulating research and fostering the interactions of scholars across health research related disciplines. Topics covered include: Health data analysis and applications to EHR data Clinical trials, FDR, and applications in health science Big network analytics and its applications in GWAS Survival analysis and functional data analysis Graphical modelling in genomic studies The book will be valuable to data scientists and statisticians who are working in biomedicine and health, other practitioners in the health sciences, and graduate students and researchers in biostatistics and health.

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials - A Regulatory Perspective.

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine - Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

This book is comprised of the presentations delivered at the 25th ICSA Applied Statistics Symposium held at the Hyatt Regency Atlanta, on June 12-15, 2016. This symposium attracted more than 700 statisticians and data scientists working in academia, government, and industry from all over the world. The theme of this conference was the "Challenge of Big Data and Applications of Statistics," in recognition of the advent of big data era, and the symposium offered opportunities for learning, receiving inspirations from old research ideas and for developing new ones, and for promoting further research collaborations in the data sciences. The invited contributions addressed rich topics closely related to big data analysis in the data sciences, reflecting recent advances and major challenges in statistics, business statistics, and biostatistics. Subsequently, the six editors selected 19 high-quality presentations and invited the speakers to prepare full chapters for this book, which showcases new methods in statistics and data sciences, emerging theories, and case applications from statistics, data science and interdisciplinary fields. The topics covered in the book are timely and have great impact on data sciences, identifying important directions for future research, promoting advanced statistical methods in big data science, and facilitating future collaborations across disciplines and between theory and practice.

This book explores different statistical quality technologies including recent advances and applications. Statistical process control, acceptance sample plans and reliability assessment are some of the essential statistical techniques in quality technologies to ensure high quality products and to reduce consumer and producer risks. Numerous statistical techniques and methodologies for quality control and improvement have been developed in recent years to help resolve current product quality issues in today's fast changing environment. Featuring contributions from top experts in the field, this book covers three major topics: statistical process control, acceptance sampling plans, and reliability testing and designs. The topics covered in the book are timely and have a high potential impact and influence to academics, scholars, students and professionals in statistics, engineering, manufacturing and health.

This book primarily aims to discuss emerging topics in statistical methods and to booster research, education, and training to advance statistical modeling on interval-censored survival data. Commonly collected from public health and biomedical research, among other sources, interval-censored survival data can easily be mistaken for typical right-censored survival data, which can result in erroneous statistical inference due to the complexity of this type of data. The book invites a group of internationally leading researchers to systematically discuss and explore the historical development of the associated methods and their computational implementations, as well as emerging topics related to interval-censored data. It covers a variety of topics, including univariate interval-censored data, multivariate interval-censored data, clustered interval-censored data, competing risk interval-censored data, data with interval-censored covariates, interval-censored data from electric medical records, and misclassified interval-censored data. Researchers, students, and practitioners can directly make use of the state-of-the-art methods covered in the book to tackle their problems in research, education, training and consultation.

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government.

This monograph provides a concise point of research topics and reference for modeling correlated response data with time-dependent covariates, and longitudinal data for the analysis of population-averaged models, highlighting methods by a variety of pioneering scholars. While the models presented in the volume are applied to health and health-related data, they can be used to analyze any kind of data that contain covariates that change over time. The included data are analyzed with the use of both R and SAS, and the data and computing programs are provided to readers so that they can replicate and implement covered methods. It is an excellent resource for scholars of both computational and methodological statistics and biostatistics, particularly in the applied areas of health.

Bayesian analysis is one of the important tools for statistical modelling and inference. Bayesian frameworks and methods have been successfully applied to solve practical problems in reliability and survival analysis, which have a wide range of real world applications in medical and biological sciences, social and economic sciences, and engineering. In the past few decades, significant developments of Bayesian inference have been made by many researchers, and advancements in computational technology and computer performance has laid the groundwork for new opportunities in Bayesian computation for practitioners. Because these theoretical and technological developments introduce new questions and challenges, and increase the complexity of the Bayesian framework, this book brings together experts engaged in groundbreaking research on Bayesian inference and computation to discuss important issues, with emphasis on applications to reliability and survival analysis. Topics covered are timely and have the potential to influence the interacting worlds of biostatistics, engineering, medical sciences, statistics, and more. The included chapters present current methods, theories, and applications in the diverse area of biostatistical analysis. The volume as a whole serves as reference in driving quality global health research.

This book is aimed to compile typical fundamental to advanced statistical methods to be used for health data sciences. This book promotes the applications to health and health-related data. However, the models in this book can be used to analyse any kind of data. The data are analysed with the commonly used statistical software of R/SAS (with online supplementary on SPSS/Stata). The data and computing programs will be available to facilitate readers' learning experience. There has been considerable attention to making statistical methods and analytics available to health data science researchers and students. This book brings it all together to provide a concise point-of-reference for most commonly used statistical methods from the fundamental level to the advanced level. We envisage this book will contribute to the rapid development in health data science. We provide straightforward explanations of the collected statistical theory and models, compilations of a variety of publicly available data, and illustrations of data analytics using commonly used statistical software of SAS/R. We will have the data and computer programs available for readers to replicate and implement the new methods. The primary readers would be applied data scientists and practitioners in any field of data science, applied statistical analysts and scientists in public health, academic researchers, and graduate students in statistics and biostatistics. The secondary readers would be R&D professionals/practitioners in industry and governmental agencies. This book can be used for both teaching and applied research.

This unique book addresses the statistical modelling and analysis of microbiome data using cutting-edge R software. It includes real-world data from the authors' research and from the public domain, and discusses the implementation of R for data analysis step by step. The data and R computer programs are publicly available, allowing readers to replicate the model development and data analysis presented in each chapter, so that these new methods can be readily applied in their own research. The book also discusses recent developments in statistical modelling and data analysis in microbiome research, as well as the latest advances in next-generation sequencing and big data in methodological development and applications. This timely book will greatly benefit all readers involved in microbiome, ecology and microarray data analyses, as well as other fields of research.

There has been considerable attention to making the methodologies of structural equation modeling available to researchers, practitioners, and students along with commonly used software. Structural Equation Modelling Using R/SAS aims to bring it all together to provide a concise point-of-reference for the most commonly used structural equation modeling from the fundamental level to the advanced level. This book is intended to contribute to the rapid development in structural equation modeling and its applications to real-world data. Straightforward explanations of the statistical theory and models related to structural equation models are provided, using a compilation of a variety of publicly available data, to provide an illustration of data analytics in a step-by-step fashion using commonly used statistical software of R and SAS. This book is appropriate for anyone who is interested in learning and practicing structural equation modeling, especially in using R and SAS. It is useful for applied statisticians, data scientists and practitioners, applied statistical analysts and scientists in public health, and academic researchers and graduate students in statistics, whilst also being of use to R&D professionals/practitioners in industry and governmental agencies. Key Features: Extensive compilation of commonly used structural equation models and methods from fundamental to advanced levels Straightforward explanations of the theory related to the structural equation models Compilation of a variety of publicly available data Step-by-step illustrations of data analysis using commonly used statistical software R and SAS Data and computer programs are available for readers to replicate and implement the new methods to better understand the book contents and for future applications Handbook for applied statisticians and practitioners

In the statistical domain, certain topics have received considerable attention during the last decade or so, necessitated by the growth and evolution of data and theoretical challenges. This growth has invariably been accompanied by computational advancement, which has presented end users as well as researchers with the necessary opportunities to handle data and implement modelling solutions for statistical purposes. Showcasing the interplay among a variety of disciplines, this book offers pioneering theoretical and applied solutions to practice-oriented problems. As a carefully curated collection of prominent international thought leaders, it fosters collaboration between statisticians and biostatisticians and provides an array of thought processes and tools to its readers. The book thereby creates an understanding and appreciation of recent developments as well as an implementation of these contributions within the broader framework of both academia and industry. Computational and Methodological Statistics and Biostatistics is composed of three main themes: * Recent developments in theory and applications of statistical distributions;* Recent developments in supervised and unsupervised modelling;* Recent developments in biostatistics; and also features programming code and accompanying algorithms to enable readers to replicate and implement methodologies. Therefore, this monograph provides a concise point of reference for a variety of current trends and topics within the statistical domain. With interdisciplinary appeal, it will be useful to researchers, graduate students, and practitioners in statistics, biostatistics, clinical methodology, geology, data science, and actuarial science, amongst others.

This book examines statistical methods and models used in the fields of global health and epidemiology. It includes methods such as innovative probability sampling, data harmonization and encryption, and advanced descriptive, analytical and monitory methods. Program codes using R are included as well as real data examples. Contemporary global health and epidemiology involves a myriad of medical and health challenges, including inequality of treatment, the HIV/AIDS epidemic and its subsequent control, the flu, cancer, tobacco control, drug use, and environmental pollution. In addition to its vast scales and telescopic perspective; addressing global health concerns often involves examining resource-limited populations with large geographic, socioeconomic diversities. Therefore, advancing global health requires new epidemiological design, new data, and new methods for sampling, data processing, and statistical analysis. This book provides global health researchers with methods that will enable access to and utilization of existing data. Featuring contributions from both epidemiological and biostatistical scholars, this book is a practical resource for researchers, practitioners, and students in solving global health problems in research, education, training, and consultation.

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the second of the 3-volume book series. The topics covered include: Statistical Approaches to the Meta-analysis of Randomized Clinical Trials, Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies, Generalized Tests in Clinical Trials, Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free , Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia, Selected Statistical Issues in Patient-reported Outcomes, Network Meta-analysis, Detecting Safety Signals Among Adverse Events in Clinical Trials, Applied Meta-analysis Using R, Treatment of Missing Data in Comparative Effectiveness Research, Causal Estimands: A Common Language for Missing Data, Bayesian Subgroup Analysis with Examples, Statistical Methods in Diagnostic Devices, A Question-Based Approach to the Analysis of Safety Data, Analysis of Two-stage Adaptive Seamless Trial Design, and Multiplicity Problems in Clinical Trials - A Regulatory Perspective.

This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments - particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter. The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine - Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.

This book focuses on how to appropriately plan and develop a Phase II program, and how to design Phase II clinical trials and analyze their data. It provides a comprehensive overview of the entire drug development process and highlights key questions that need to be addressed for the successful execution of Phase II, so as to increase its success in Phase III and for drug approval. Lastly it warns project team members of the common potential pitfalls and offers tips on how to avoid them.

Multivariate statistical analysis has undergone a rich and varied evolution during the latter half of the 20th century. Academics and practitioners have produced much literature with diverse interests and with varying multidisciplinary knowledge on different topics within the multivariate domain. Due to multivariate algebra being of sustained interest and being a continuously developing field, its appeal breaches laterally across multiple disciplines to act as a catalyst for contemporary advances, with its core inferential genesis remaining in that of statistics. It is exactly this varied evolution caused by an influx in data production, diffusion, and understanding in scientific fields that has blurred many lines between disciplines. The cross-pollination between statistics and biology, engineering, medical science, computer science, and even art, has accelerated the vast amount of questions that statistical methodology has to answer and report on. These questions are often multivariate in nature, hoping to elucidate uncertainty on more than one aspect at the same time, and it is here where statistical thinking merges mathematical design with real life interpretation for understanding this uncertainty. Statistical advances benefit from these algebraic inventions and expansions in the multivariate paradigm. This contributed volume aims to usher novel research emanating from a multivariate statistical foundation into the spotlight, with particular significance in multidisciplinary settings. The overarching spirit of this volume is to highlight current trends, stimulate a focus on, and connect multidisciplinary dots from and within multivariate statistical analysis. Guided by these thoughts, a collection of research at the forefront of multivariate statistical thinking is presented here which has been authored by globally recognized subject matter experts.

Bayesian analysis is one of the important tools for statistical modelling and inference. Bayesian frameworks and methods have been successfully applied to solve practical problems in reliability and survival analysis, which have a wide range of real world applications in medical and biological sciences, social and economic sciences, and engineering. In the past few decades, significant developments of Bayesian inference have been made by many researchers, and advancements in computational technology and computer performance has laid the groundwork for new opportunities in Bayesian computation for practitioners. Because these theoretical and technological developments introduce new questions and challenges, and increase the complexity of the Bayesian framework, this book brings together experts engaged in groundbreaking research on Bayesian inference and computation to discuss important issues, with emphasis on applications to reliability and survival analysis. Topics covered are timely and have the potential to influence the interacting worlds of biostatistics, engineering, medical sciences, statistics, and more. The included chapters present current methods, theories, and applications in the diverse area of biostatistical analysis. The volume as a whole serves as reference in driving quality global health research.  

This book brings together the voices of leading experts in the frontiers of biostatistics, biomedicine, and the health sciences to discuss the statistical procedures, useful methods, and novel applications in biostatistics research. It also includes discussions of potential future directions of biomedicine and new statistical developments for health research, with the intent of stimulating research and fostering the interactions of scholars across health research related disciplines. Topics covered include: Health data analysis and applications to EHR data Clinical trials, FDR, and applications in health science Big network analytics and its applications in GWAS Survival analysis and functional data analysis Graphical modelling in genomic studies The book will be valuable to data scientists and statisticians who are working in biomedicine and health, other practitioners in the health sciences, and graduate students and researchers in biostatistics and health.

This monograph provides a concise point of research topics and reference for modeling correlated response data with time-dependent covariates, and longitudinal data for the analysis of population-averaged models, highlighting methods by a variety of pioneering scholars. While the models presented in the volume are applied to health and health-related data, they can be used to analyze any kind of data that contain covariates that change over time. The included data are analyzed with the use of both R and SAS, and the data and computing programs are provided to readers so that they can replicate and implement covered methods. It is an excellent resource for scholars of both computational and methodological statistics and biostatistics, particularly in the applied areas of health.