Donna LaLonde

The mission of the American Statistical Association (ASA) is to promote the practice and profession of statistics. The members of the ASA act on this mission through their work and service. Over the many decades of his career and through his actions, Samuel “Ed” Nevius fulfilled this mission on unprecedented levels. Ed died on December 15, 2022. It is an honor to share a brief biography and remembrances from his colleagues.

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Ed grew up in the Sunflower State on the family farm. He matriculated to the University of Kansas, becoming a Jayhawk and earning a bachelor’s degree in mathematics. Although he graduated in 1967, he followed KU basketball throughout his life. Ed also earned a master’s degree from Kansas State University, and received his PhD in statistics from Florida State University in 1975. After completing his PhD, he was a faculty member in the Department of Mathematics and Statistics at the University of Nebraska. In January 1979, he moved to the Washington, D.C., area, where he began work as a statistician for the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA). He dedicated the rest of his career to the FDA and retired as deputy director of the Office of Biostatistics in 2016.

Remembrances

These are remembrances shared by colleagues.

Dionne Price, Deputy Director, Office of Biostatistics, FDA

It is extremely challenging to articulate the tremendous impact that Dr. Ed Nevius had on me and so many others in the FDA and beyond. Ed gave new meaning to the phrase “gentle giant.” He was a giant of a leader, using his intellect to gently guide and mentor both statisticians and non-statisticians. Ed’s quiet demeanor was his strength as he ensured that scientifically sound conclusions were reached that benefited public health.

In the ASA, Ed was a constant volunteer, again using his intellect and unassuming manner to promote the practice and profession of statistics. Ed was undeniably influential, and I sincerely believe that we, as a profession and a people, are better because of him.

ShaAvhrée Buckman-Garner, MD, PhD, Director, Office of Translational Sciences, Center for Drug Evaluation & Research

I am very grateful to have met and learned from Dr. Nevius since the inception of the Office of Translational Sciences in 2006. Ed was always kind, compassionate, knowledgeable, and willing to go above and beyond to help mentor, guide, and support staff in the Office of Biostatistics. His dedication and commitment to the work of the FDA and the field of statistics, with a life dedicated to public service, was beyond exemplary. The impact of his legacy is evidenced by the number of staff whom he recruited, mentored, and supported directly, which built and reinforced the foundation for the Office of Biostatistics to become the shining example that it is today.

Aloka G. Chakravarty, Director, Data Analytics, Office of the Commissioner

I met Ed when I came in to interview at Office of Biostatistics (OB) FDA in 1992. He was one of the interviewers; I was immediately touched by his kind nature when he showed up with a cup of water for me. Since then, Ed was my lifelong mentor—he always had a pragmatic answer, be it technical or otherwise. He always knew whom to ask, where to look, and what to look for. Ed always made time for you, no matter how busy he was.

Over the years, we became close associates. I came to rely on his deep knowledge of the agency, network of colleagues, and organizational memory. He was deeply respected inside and outside of FDA. I had trepidation about big shoes to fill when he retired and I became the deputy director of OB in his stead. Ed spent hours showing me his meticulously filed documents and filling me in on transition details. I do not know what I would have done otherwise!

Robert ONeil, retired Senior Statistical Advisor, Center for Drug Evaluation & Research, Office of Translational Sciences

Ed Nevius and I came to the FDA in the 1970s, when it was called the Bureau of Drugs in the FDA. Over the years, the name was changed to the Center for Drug Evaluation, and then to the Center for Drug Evaluation and Research. This latter change was important because it recognized and promoted the regulatory research component of the FDA.

We both began our careers as statistical reviewers of New Drug Applications, essentially evaluating the quality of evidence of drug efficacy and safety in the clinical trials submitted to FDA by pharmaceutical sponsors seeking approval for marketing. The 1970s were a different time, lacking any written guidance about clinical trial evidence evaluation, or a process for the review of new drug applications and clinical trials that considered statisticians as part of the review team and not just consultants to the clinical staff who also reviewed New Drug Applications.

It was also at a time where the clinical studies submitted to FDA were often lacking in their design, the appropriate statistical analysis—not to say even a prior statistical analysis plan—and industry study protocols submitted to the FDA. No biostatistician had to have sign-off authority to vouch for its quality.

The FDA was also in a period of evaluating evidence of efficacy of all drugs placed in the market from 1939 to 1962, when there were no regulatory standards for efficacy, because the 1968 Harris-Kefauver efficacy law did not yet exist. This evaluation process was separate from the NDA evaluation process, but was similar to a legal proceeding, because sponsors could argue for their evidence in front of an FDA administrative judge—a unique and very informative process at the time, where FDA statisticians bore the significant burden of testifying about the quality and quantity of evidence for drug efficacy.

This was the environment that Ed Nevius came to at the FDA. He helped change many of the unstructured practices and persuaded the clinical staff to appreciate and accept the statistical conclusions of our review process. He was one of the few FDA statisticians who testified before the administrative judge about his evaluation of evidence from the statistical perspective of these 1939–1962 drugs on the market without demonstrated evidence, and he was persuasive in providing the judgment in favor of the FDA. This effort contributed to the groundwork for how the FDA reviews evidence today, and indeed the foundations of the biostatistics program at the FDA.

Aside from that early statistical review work during the 1970s, Ed continued to contribute to the growth of the biometrics program during the late 1970s, 1980s, 1990s, and up to his FDA retirement. During all this time, he brought his level-headed statistical advice to the clinical staff he supported, and helped shape and develop many of the regulatory guidances that became standards for the United States and eventually internationally within the International Conference for Harmonization framework (Europe, Japan, and the United States).

Over the course of his FDA career, Ed evolved into a topnotch manager and administrator of the statistical program, which began as a single Division of Biometrics with fewer than 25 staff, and grew into an Office of Biostatistics that contained upward of eight divisions with more than 200 staff and other support as of the time he retired. He was always on top of the issues, the regulations, the organizational implications of decisions—but was quietly so. His advice was sought by all.

I was fortunate to have Ed as my deputy when I assumed the role of director of the Office of Biostatistics from Dr. Chuck Anello, father of the biostatistics program for drugs. Ed was my right hand for as long as I held that position and I relied on him for numerous organizational, personnel, and evidence decisions. Ed was a constant source of insight and advice. I was very lucky to have him help me during that period.

As the biostatistics program grew, recruitment for new talent increased and the office was provided with resources to hire new statisticians. Ed was the point person for this, since it also involved his ASA connections and recruiting savvy. He was responsible in large part for the talent base in the current Office of Biostatistics.

While it is sad to recognize Ed’s passing, I am honored to be able to write a few words that reflect the substantial contributions he made to FDA, the profession, and the culture of the program that currently exists.

John Leahy, IT Specialist, FDA

I met Ed in back 1987 when I transferred into the Division of Biometrics as a statistical assistant. He had a strong interest in IT, and he saw this as a career path for me. With this, he changed the trajectory of my life for the better.

Ed was always looking for ways to improve our work product, our work environment, and our work life. It was with his vision and leadership that we created one of the very first Apple/Macintosh printer networks at the FDA, in the Parklawn building in Rockville.

I had the good fortune of having Ed as my mentor and supervisor for many years. He was always kind, patient, personable, and brilliant. I was always amazed at his ability to accomplish all the great things he did while still finding time for all of us who worked with him. One of my fondest memories is preserved in the two photos I have of Ed holding my daughter at our division meeting, when she was six months old.

Ed touched so many lives in so many ways. He was a light, and I am really going to miss him.

Wanjie Sun, Senior Mathematical Statistician, FDA

Ed was the first one I talked to on my interview day. I still remember how humble he was. He asked me whether I would like tea. I nodded casually. Then, to my surprise, he walked all the way down the hall to get hot water and served me a cup of tea. I was so touched. He would put in so much effort as a senior—an office deputy director—for a random young candidate. That was Ed.

Rest in peace, Ed. You will be dearly missed.

Karen Higgins, Supervisory Mathematical Statistician, FDA

Whenever I needed a quick break, I knew I could stop by Ed’s office for a piece of candy, and if I was lucky enough to find him in his office, a nice little check-in with him about life or happenings at the FDA.

He was my “go to” person regarding any odd question I might have, and he always knew the right direction to send me. I am so grateful to have known him.

Meiyu Shen, Lead Mathematical Statistician, FDA

I have known Ed since I worked on the former Quantitative Research Staff (QMR) some years ago. As the promotion chair at the Office of Biostatistics, Ed valued QMR’s work on statistical consultation and research critical to support the agency’s core business (applications evaluation). Over years, his leadership and kindness have inspired me to overcome the challenges from reviews, statistical research, and beyond. Having been the deputy director of the Office of Biostatistics for a long time, Ed was strategic and visionary.

He was very kind in offering me help at the personal level when needed.

Ed will be missed beyond measure. His legacy will live on.

Pallavi Mishra-Kalyani, Supervisory Mathematical Statistician, FDA

Like many others who met Dr. Nevius near the end of his FDA career, I met Ed while interviewing with the Office of Biostatistics. I was about seven months’ pregnant with my first child at the time, and Ed spent our interview time talking about the joys of a young family, work-life balance at the FDA, and the exciting time ahead for me. He took extra-special care of me all day, checking in to see if I needed any water or rest as I interviewed.

After I joined the FDA, Ed was so generous with his time, and would always ask about me both as a professional and as a new mother. Getting to know him, I found that he was both scientifically brilliant and extraordinarily kind, providing us all with an example of a wonderful and compassionate leader. Rest in peace, Dr. Nevius.

Yuan-Li Shen, Biostatistician, FDA

Ed was always a nice and gentle person. I didn’t feel he was in the higher-up even though I was just a new reviewer. He was like a guy next door, easy to get into conversation with anywhere. He had a wealth of knowledge about the issues around the office. Even though we never worked in the same division or on projects together, I seemed to find myself consulting him all the time. He always had the magic advice that helped me resolve the issues.

Ed did so much for us, but seemed to always stay so grounded. I’ll always remember him for his manner toward people and dedication toward the work.

Karl Lin, Mathematical Statistician, FDA

I worked under Ed when he was director of the Division of Biometrics 3. He was a hard-working supervisor. Often, he came to his office to work on Saturdays. I am grateful to have had the opportunity to work with such a great supervisor who cared so deeply about his team members. He was my manager, mentor, and friend.

Lei Nie, Director, Division of Biometrics IV, FDA

My wife met Ed in 2006, and I met him in 2007 after joining the FDA. While the memory of early interactions have faded away, our memories of his kindness, calm manner, caring nature, and compassion never aged a day. As the deputy office director, Ed was juggling multiple tasks, but he still had time for all of us. We were always felt comfortable about sharing our successes, struggles, and challenges with him because he listened patiently and never jumped to conclusions. As a kind leader, he had always his colleagues’ interests in his big heart. He unknowingly inspired many of his colleagues to become leaders with compassion, so his legacy has been carried on.

James Hung, Director, Division of Biometrics I, FDA

Ed always helped a great deal to resolve issues, especially administrative matters, regardless of how challenging they could be. He always reminded us of all the things that matter, regardless of whether they are small. He paid much attention to every request or inquiry from me. He was so nice, gentle, professional, and caring. I will miss him dearly.

Mat Soukup, Deputy Director, Division of Biometrics VII, FDA

Ed was remarkable in so many ways; ways that were not bold or loud, but calm, thoughtful, and pure. His actions were not for personal gain, but for others. These qualities allowed Ed to achieve success in the field of statistics and influenced many of us statisticians—me included. Ed will be missed immensely, but his impacts on the field of statistics will endure due to his selfless contributions over his career.

Mohammad Atiar Rahman, Deputy Director, Division of Biometrics VI, FDA

Ed was my colleague since 1991. Even though we were working in two different branches, I got many tips and help from him to smoothly start my FDA life. During my long journey in the FDA, I got help from Ed on so many occasions that I cannot list. I heartily appreciated his selfless help in preparing my promotion packages for Grade 14 and 15. Right before his retirement, he very carefully read my long book chapter and suggested many improvements.

As a person, he was very soft-spoken and polite. I am ever thankful and indebted to him. May his soul remain in eternal peace.

Mark Levenson, Director, Division of Biometrics VII, FDA

Ed’s impact cannot be overstated. He had the most institutional knowledge of anyone in the office, whether for statistical, regulatory, or administrative concerns. As many in the office experienced, Ed always had time for you. He was always patient and always effective. No matter how tense the situation, Ed remained calm and worked through the situation. He is someone to aspire to as a colleague, leader, and friend.

Paul Schuette, Mathematical Statistician, FDA

Ed was the canonical example of a servant leader. Ed had an open-door policy, and many will recall that he always had a jar of chocolates by the entrance. Ed was thoughtful, courteous, and kind.

After the untimely death of Ferrin Harrison in 2009, Ed asked me to take on Ferrin’s role of dealing with the scientific computing needs of the office. Eventually, I reported directly to Ed, who was very supportive of efforts to improve the computational environment for reviewers in the Office of Biostatistics and also encouraged me to apply for a promotion.

Ed genuinely cared about the staff in the office and about the FDA as an institution. Even after he retired, Ed returned to share his wisdom and contributed to work on guidance documents. He will certainly be missed by his former colleagues as well as his family.

Fairouz Makhlouf, Deputy Director, Division of Biometrics VIII, FDA

Ed was a great leader. He was compassionate, thoughtful, and caring. He was supportive to all of us in the Office of Biostatistics. He cared about each of us and always had a solution to our problems. I will always remember him.

Stella Grosser, Director, Division of Biometrics VIII, FDA

Ed Nevius hired me and was my initial division director in the Office of Biostatistics. Like many others, I first met Ed when I interviewed for a position as a reviewer. During our talk, he asked me, reasonably enough, what I was looking for in my next job (I was coming from a faculty position). I froze—I’m terrible at this kind of stuff—and in the silence, he gently suggested, “Perhaps something to do with clinical trials?” “Yes!” I said, “that’s it!” “Well,” he said, “you’ve come to the right place.”

And he was prescient: I’d come to the right place. Not because CDER is at the heart of the American clinical trial ecosystem, but because he was at the heart of biostatistics at CDER. Over two decades with Ed as my supervisor and advisor, I came to rely on his statistical, regulatory, and managerial wisdom. His institutional knowledge was remarkable; his ability to apply it in a way that benefited the staff and the drug review process even more so.

He was kind and smart and patient. I’ve missed him since he retired for a second time a few years ago and will miss him even more now.

Alexei C. Ionan, Mathematical Statistician, FDA

My journey in the Office of Biostatistics started with Ed, an excellent scientist and regulator, a kind and caring person. A tremendous wave of gratitude expressed by colleagues at his retirement event reflected, at least in part, his positive impact on many lives in the Office of Biostatistics, but his impact reached much further: Many patients must have benefited from his valuable contributions to the public health over the decades.

Ed’s personal and professional excellence is an inspiration.

Laura Lee Johnson, Director, Division of Biometrics III, FDA

When I interviewed in the office, Ed was charged with finding a way to get me from NIH to the FDA. He came up with several options, and we kept moving through them until one worked out. He would gently prod me about advancing my career and gave me sage advice about how to help others.

He had knowledge about everything—statistics, regulation, administration, history, human nature, supervision, caring for others—the list could go on. I also knew that if he did not have the answer, he would say so and point me in the right direction.

I miss his smile. Our Alaska stories, decades apart. His dedication to service, and the love we saw emanate from him toward his family and others, live on in all of us.

Final Thoughts

In the introduction, we stated the mission of the ASA. These remembrances of the career and impact of Ed Nevius reinforce that we make progress because of the contributions of individuals. The practice of statistics is promoted by the many individuals like Ed Nevius who are committed stewards of the profession.

About the Author

Donna LaLonde is the associate executive director at the ASA, where she works with colleagues to advance the vision and mission of the association. Before joining the ASA, she was a faculty member at Washburn University and served in various administrative positions, including interim chair of the Education Department and associate vice president for academic affairs. At the ASA, LaLonde has supported activities associated with presidential initiatives, professional development, and accreditation.

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