The History of the Biopharmaceutical Section of the American Statistical Association

Originally sourced from a poster presented at the 2014 Joint Statistical Meetings authored by Matilde Sanchez-Kam, Amit Bhattacharyya, and Dionne Price 

The Biopharmaceutical (BIOP) Section of the American Statistical Association (ASA) was established in 1968 as a sub-section of the Biometrics Section. It was initially called the Pharmaceutical Subsection and was first subsection of the ASA. After 12 years, given its tremendous growth in membership, the subsection was inducted into the ASA as a full section in 1981. The Biopharmaceutical Section is now one of the most active sections of the ASA. BIOP annually sponsors the Regulatory/Industry Statistics Workshop which has been successful in uniting statisticians from both the FDA and the pharmaceutical industry, allowing for scientific discussions of statistics applied to drug development.   BIOP also sponsors the biennial Nonclinical Biostatistics Conference.  Over its long history, the section continues to offer members valuable benefits such as web-based training series, contributed paper awards and contributed poster awards.  




BIOP YouTube Channel initiated


Scholarship award initiated


Nonclinical Biostatistics joins the section


20th Anniversary of the Regulatory-Industry Statistics Workshop


Launch of the Mentoring Program


First Podcast


Best Poster Award


ASA journal “Statistics in Biopharmaceutical Research (SBR)”. First editor: Joe Heyse


First webinar


ASA Biopharmaceutical Section Regulatory/Industry Statistics Workshop


Creation of BIOP Website


Creation of Best Student Paper Award


Biopharmaceutical Report.  First editor: Avital Cnaan


Creation of Best Contributed Paper Award


Short course on “Fundamentals of Clinical Trials” by Dave DeMets and Gordon Lan


Manual of Operations


Established as a section of the ASA


Established as subsection of the ASA






Alan Hartford


Weili He


Bruce Binkowitz


Richard C. Zink 


Heather Thomas



Alex Dmitrienko


B. Christine Clark


Dionne Price


Matilde Sanchez-Kam


Amit Bhattacharyya


Steve Gulyas


Stephen Wilson


Katherine Monti


Anna Nevius


Kannan Natarajan


Brian Wiens


Stacy Lindborg


Len Oppenheimer


Keith Soper


Nancy D. Smith


Robert Small


Jeff Meeker


Thomas Capizzi


Steven Snapinn


Ken Koury


Robert Davis


Gary L. Neidert


Lilliam Kingsbury


Robert R. Starbuck


Bruce E. Rodda


Camilla Brooks


Gladys H. Reynolds


Karl Peace


Vern Chinchilli


John Schultz


Charlie Goldsmith


Paula Norwood


David Gaylor


Kathleen Lamborn


Wanzer Drane


Roger Flora


Ralph Buncher



Carl Metzler


Charlie Sampson


Wilf Westlake


Dave Salsburg


Marti Hearron


Bob Assenzo


Joe Meyer


Ted Colton


Joe Ciminera


David Bray


Charlie Dunnett

1968 - 1969

Joe Dresner


1966 - 1967

Joe Dresner

  • 2006: ASA Board of Directors approved creation of a Special Interest Group on Devices under the Biopharmaceutical Section.
  • 2007: The first issue of the ASA journal “Statistics in Biopharmaceutical Research” came out. Joe Heyse was named the first editor. The journal was created to specifically address the growing needs of the application of statistics in biopharmaceutical sciences.
  • 2007: The Biopharmaceutical Section launched a web-based distance training program through the leadership of Alex Dmitrienko. The Biopharmaceutical Section was the first section to sponsor a webinar/distance learning seminar. This had a significant impact and has led many other sections to start their own series.
  • 2009: The Biopharmaceutical Section established a Poster Competition to recognize the significant work presented in poster form, increase the number of posters, and improve the quality of the posters at JSM. Yongming Qu spearheaded this initiative and served as the first chair of the Biopharmaceutical Section Poster Award Committee.
  • 2010: The Biopharmaceutical Section sponsored website ““A Career in Biopharmaceutical Statistics” went live. It was designed to expose high school and undergraduates to biostatistics as a profession. Steve Gulyas was the driving force behind the Web Outreach Project.
  • 2012: As part of Continuing Education Initiative of enhancing current educational material with audio and video content, podcasting was promoted. This initiative was proposed by Rima Izem.
  • 2014: The Biopharmaceutical Section thru the leadership of Matilde Sanchez-Kam initiated the formation of Scientific Working Groups to encourage collaboration and scientific discussions of statistical issues in drug development among industry, regulatory and academic statisticians.
  • 2014: The Biopharmaceutical Section initiated a Mentoring Program spearheaded by Jennifer Gauvin and Amarjot Kaur.

  • January 1, 1981: At least 500 ASA Members elected to join the proposed Biopharmaceutical Section, which officially came into existence on this day. Thus, the new Biopharmaceutical Section became only the eighth in existence at ASA.
  • 1983: The Section accomplished another milestone with the creation of a Manual of Operations to assist section officers.
  • The mid-1980s brought a new initiative of focused research for the Section. In 1983, a Future Goals Committee was created under the umbrella of the ASA Biopharmaceutical Section Work Groups, chaired by Karl Peace. Twelve “working groups” considered special topics ranging from “Positive Control or Active Control Equivalence Studies” to “Pooling of Data”, and from “Analysis of Trials with Incomplete Data” to “Dual Control Groups in Rodent Carcinogenicity Studies” which resulted in a 1990 book: “Statistical Issues in Drug Research and Development”, edited by Karl Peace.
  • Early in 1985, David Gaylor and other government statisticians organized the Section’s first symposium on long-term animal carcinogenicity studies in Bethesda, MD, and over 200 people attended this successful meeting.
  • The need for support for planning and organizing the vast technical programs of the section became evident in the late 1980s. Early in 1987, the 3-year positions of Program Chair-elect, Program Chair, and Section Fellow Committee were created to address the needs.
  • 1991: The Biopharmaceutical Section Best Contributed Paper Award was created to encourage better presentations for Section-sponsored sessions at JSM. The 3 winning papers of the first awards were: (1) Pharmacodynamics of Analgesia Produced by Morphine and One of its Metabolites by H. T. Thaler, et.al. from Memorial Sloane-Kettering Cancer Center; (2) A New Statistical Method for Analyzing the CHO/HGPRT Mutation Assay by AJ Roth from Searle; and (3) Ratio Estimates, the Delta Method and Quantal Response Tests for Increased Carcinogenicity by GS Bieler and RL Williams from Research Triangle Institute.
  • 1992: The Biopharmaceutical Section logo was designed by Nina Mocniak.
  • 1994: The Biopharmaceutical Section Best Student Paper Award was created as a commitment to developing students in the biopharmaceutical area.
  • 1996: The Biopharmaceutical Section Website went “live” in March.
  • 1997: The Section sponsored a workshop on “FDA/Industry: Working Together to Expedite the Development of New Pharmaceutical Products” in October. Presenters include statisticians from industry, FDA and academia. One objective of the workshop was to create a congenial environment to foster exchange between FDA and industry statisticians. This served as the precursor of the ASA Biopharmaceutical Section Regulatory/Industry Statistics Workshop.

  • 1978: Due to the ever-increasing size and scope of the subsection, momentum towards obtaining full section status gained strength.
  • The BPSS Executive Committee began aggressively pursuing and strategizing for full-section status in late 1978 and early 1979. Charlie Sampson, Marti Hearron, and Kathleen Lamborn began a review of the original charter. Simultaneously, the group approached Fred Leone (Executive Director, ASA) about the possibility of the BPSS receiving full-section status. Dr. Leone was extremely supportive and assisted the BPSS leadership in crafting a plan.
  • An equally integral component of Dr. Leone’s plan was a strategy for gaining support from many committees and factions in the ASA. A year and a half of lobbying and discussion led to strong support from many key figures within ASA.
  • On February 1, 1980, in Washington DC, the ASA Board of Directors approved the petition of the Biopharmaceutical Subsection to full-Section status. The question would then be put on the national ballot in May 1980 with the stipulation that if at least 500 members indicated that they will join the proposed Section, it would come into existence on January 1st, 1981.

  • Began as an indirect result of various Congressional acts to mandate the conduct of clinical trials.
  • Newly hired individuals in the pharmaceutical industry sought a professional platform for technical and developmental support in this new field.
  • 1966: Concept of a formal pharmaceutical industry-oriented interest group was first discussed at the ASA meeting in Los Angeles.
  • 1968: Established as an informal group that quickly organized and grew into a subsection of the Biometrics Section of the ASA. It was the first subsection of the ASA and was called the Biopharmaceutical Subsection (BPSS).
  • FDA statisticians originally could not be active in any groups involving external organizations, such as BPSS or Pharmaceutical Manufacturers Association (PMA, now known as PhRMA). An FDA policy change in the early 1970s allowed more FDA participation in pharmaceutical statistics meetings, and the BPSS became a resource for FDA.
  • In response to FDA requests, the BPSS assisted in the identification of qualified committee members to serve on various advisory committees, a first general collaborative effort between the FDA and industry.
  • The BPSS liaised with other key organizations and focused attention on the areas of need for statisticians in the pharmaceutical industry such as pharmacokinetics, clinical trials, protocol design, multi-center considerations, and sample size.
  • The BPSS and its meetings provided a mutually beneficial forum for industry and FDA statisticians to discuss statistical methodology. These interactions led to the creation of the PMA Biostat Committee.
  • The BPSS enjoyed the benefits and pains of steady growth during the 1970s. During the timeframe of 1966-1979, the membership of the BPSS grew from 100 to approximately 1500.
  • Due to the Delaney Amendment (1958), which dealt with testing compounds for carcinogenic potential in preclinical toxicology research domain, demand for statistical input was created in the pre-clinical arena. As more and more academic biostatisticians recognized the fertile field and wide variety of problems in this arena, more balance and credibility was added to the growing membership of BPSS.

  • One of the largest sections of the ASA
  • Excellent networking opportunities
  • Sponsor of the annual ASA Biopharmaceutical Section FDA-Industry Statistics Workshop
  • Numerous avenues for professional development
  • Section activities such as the Mentoring Program & Scientific Working Groups
  • Popular webinar series with topics relevant to biopharmaceutical statisticians
  • Outreach initiatives to promote the profession
  • Discounted registration fees for various conferences and webinars
  • Access to our community news forum and the Biopharmaceutical Report
  • Minimal membership fee


Davis, R., et al (2005). ““The History of the Biopharmaceutical Section of the American Statistical Association (ASA), 1966-1988.” Biopharmaceutical Report, Vol. 13, No. 1.

Free, Spencer Jr. (1990). “Some History for the Biopharmaceutical Section.” The American Statistician, Vol. 44, No. 22.