Contemporary Biostatistics with Biopharmaceutical Applications
暫譯: 當代生物統計學與生技藥物應用

本編輯書籍呈現了生物統計學的最新研究，重點在於生物製藥的應用。該書收錄了2017年6月25日至28日在伊利諾伊州芝加哥舉行的2017 ICSA應用統計研討會上發表的貢獻，探討了對統計方法學和未來生物統計學及生物製藥研究具有高度潛在影響的及時主題。本次會議的主題為「新一代的統計學：挑戰與機遇」，以表彰新一代統計學家的到來。會議吸引了來自學術界、政府和產業的統計學家，以及國內外的統計學家。編輯從會議中選擇了28個高品質的報告，並邀請演講者為本書撰寫完整章節。這些貢獻分為四個部分：第一部分 生物統計方法學，第二部分 統計遺傳學與生物資訊學，第三部分 監管統計，第四部分 生物製藥研究與應用。

本書涵蓋了遺傳學中的統計學、生物資訊學、生物統計方法學和統計計算等主題，對生物統計學和生物製藥領域的研究者、學者、實務工作者和政策制定者均有益處。

Lanju Zhang is Director in Statistics and Research Fellow at the Department of Data and Statistical Sciences at AbbVie. He is leading a group providing statistical support to emerging immunology clinical programs. Prior to that, he was Head of Nonclinical Statistical Group at Abbvie and MedImmune. His research interests include adaptive design, multi-region clinical trials, real world evidence, and nonclinical statistics. He has published two books (both with Springer) and more than 30 papers. He is an associate editor of Journal of Biopharmaceutical Statistics. He received his PhD in Statistics in 2005 from University of Maryland Baltimore County.

Ding-Geng Chen is a Fellow of American Statistical Association and currently the Wallace H. Kuralt Distinguished Professor at the University of North Carolina at Chapel Hill. He was a professor at the University of Rochester and the Karl E. Peace Endowed Eminent Scholar Chair in Biostatistics at Georgia Southern University. He is also a senior statistics consultant for biopharmaceuticals and government agencies with extensive expertise in Monte-Carlo simulations, clinical trial biostatistics and public health statistics. Professor Chen has more than 150 referred professional publications and co-authored and co-edited 18 books on clinical trial methodology, meta-analysis and public health applications and he has been invited nationally and internationally to give speeches on his research.

Hongmei Jiang is an associate professor of statistics at Northwestern University. Her current research focuses on developing statistical methods and computational algorithms to analyze and understand the massive amount of data generated by high throughput biological technologies, such as microarray and next generation sequencing technologies. She has published over 40 research articles in statistics and biostatistics research fields. She was the Co-Chair for the 26th ICSA Applied Statistics Symposium, which was successfully held in Chicago in June 2017.

Gang Li is a scientific director, RWE Analytics at Janssen R&D US. He is an elected fellow of the American Statistical Association. Dr. Li received his PhD from the State University of New York at Binghamton. Gang has genuine interest in statistical research and has published a number of papers on multi-regional clinical trials, adaptive design and dose finding, and non-inferiority study design in leading statistical journals.

Hui Quan received his PhD in statistics from Columbia University in 1990. He is currently an associate VP and global head of the methodology group at the Biostatistics and Programming Department of Sanofi. He has 26 years of pharmaceutical industry experience in many therapeutic areas ranging from early phase to Phase IV studies. He has published 93 papers including 69 statistical papers. He is a co-author/co-editor of two books. He has also served as an associate editor for two journals. His research interests include multivariate analysis, safety analysis, multiplicity adjustment, missing data handling, adaptive design, integrated data analysis, modeling and simulation, benefit/risk assessment and multi-regional clinical trials. He was elected as a fellow of the American Statistical Association in 2008.

編輯介紹：

張蘭菊是AbbVie數據與統計科學部的統計主任及研究員。他負責領導一個團隊，為新興的免疫學臨床計畫提供統計支持。在此之前，他曾擔任AbbVie和MedImmune的非臨床統計小組負責人。他的研究興趣包括自適應設計、多地區臨床試驗、實證數據和非臨床統計。他已出版兩本書（均與Springer合作）及超過30篇論文。他是Journal of Biopharmaceutical Statistics的副編輯。他於2005年在馬里蘭大學巴爾的摩縣校區獲得統計學博士學位。

陳丁耕是美國統計學會的會士，目前擔任北卡羅來納大學教堂山分校的Wallace H. Kuralt傑出教授。他曾是羅徹斯特大學的教授及喬治亞南方大學的Karl E. Peace生物統計學傑出學者。他同時也是生物製藥和政府機構的高級統計顧問，擁有豐富的蒙地卡羅模擬、臨床試驗生物統計學和公共衛生統計的專業知識。陳教授擁有超過150篇的專業期刊論文，並共同撰寫和編輯了18本有關臨床試驗方法學、統合分析和公共衛生應用的書籍，他曾在國內外受邀演講，分享他的研究成果。

姜紅梅是西北大學的統計學副教授。她目前的研究專注於開發統計方法和計算算法，以分析和理解由高通量生物技術（如微陣列和下一代測序技術）產生的大量數據。她在統計學和生物統計學研究領域已發表超過40篇研究文章。她曾擔任第26屆ICSA應用統計研討會的共同主席，該會議於2017年6月在芝加哥成功舉行。

李剛是Janssen R&D US的科學主任，負責RWE分析。他是美國統計學會的當選會士。李博士在紐約州立大學賓漢頓校區獲得博士學位。李剛對統計研究有濃厚的興趣，並在領先的統計期刊上發表了多篇有關多地區臨床試驗、自適應設計和劑量尋找及非劣性研究設計的論文。

全輝於1990年在哥倫比亞大學獲得統計學博士學位。他目前是賽諾菲生物統計與編程部的副總裁及全球方法學小組負責人。他在製藥行業擁有26年的經驗，涵蓋從早期階段到第四期研究的多個治療領域。他已發表93篇論文，其中69篇為統計論文。他是兩本書的共同作者/共同編輯，並曾擔任兩本期刊的副編輯。他的研究興趣包括多變量分析、安全性分析、多重性調整、缺失數據處理、自適應設計、整合數據分析、建模與模擬、效益/風險評估及多地區臨床試驗。他於2008年被選為美國統計學會的會士。