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Q&A

When did you realize you wanted to become a biostatistician and computer scientist?

Growing up in the 70s and 80s I was fascinated by electronics and the ability to program computers. I had never heard of clinical research, let alone biostatistics. After studying science in high school, I pursued a five year undergraduate/graduate program at the Indian Institute of Technology with courses in engineering and a focus on statistics. This earned me an assistantship to the US to jointly do a PhD in statistics and a MS in computer science. In 1986, two years into the program, I was asked to program in SAS to analyze clinical data. As the saying goes…the rest is history.

In your opinion, what is the greatest challenge in your field?

The greatest challenge for biostatisticians involved in clinical research is to be able to take complex concepts such as statistical methods and explain them in simple, non-technical terms in order for people to understand the results from their perspective. With the explosion of the amount of data, there are more complex statistical models and computer algorithms, such as neural networks, for machine learning being applied. Understanding how these work, validating them, and explaining them to colleagues in simple terms is the greatest challenge for data scientists.

Where do you see your field going? What is your vision of the field in 2030?”

I see biostatistics moving towards greater use of visualizing data. With the continuing increase in the number of statistical tables, figures, and listings the time and cost to generate, review, and interpret these has become prohibitive. Visualizing data using standardized static and dynamic displays that present data efficiently will allow companies developing medical products and regulators to evaluate these compounds together. The current process is sequential and inefficient. My vision for 2030 is for sponsors and regulators to review efficacy and safety of medical products collaboratively in real time using agreed-to displays.

What book are you currently reading and why?

21 Lessons for the 21st Century by Yuval Noah Harari, after reading Sapiens and Home Deus by him. I highly recommend all of his books, but if you are short on time just read 21 Lessons.

What advice would you give your younger self about to enter the “real world?”

Take time to understand yourself by listening to what others, who are honest with you, tell you. Take self-assessments like the Myers-Brigs, DISC etc. Know your strengths and limitations. Focus on capitalizing on your strengths. Understand what excites you every day, what energizes you, what do you like to do first over and above anything else every day when you get to work. Once you find something that you are really good at and you really enjoy doing, make that your career. Keep learning something new every day, even if it’s reading for 15 minutes.

How has DIA helped you?

After becoming a DIA member early in my career, I chose to attend DIA conferences initially in the US, then in Europe, China, and India. I eventually chaired and organized conferences and webinars. This allowed me to meet a diverse group of people and become aware of opportunities I did not know existed. Recognizing the benefits of being a DIA member, I became actively involved with DIA’s communities, realizing that even a small time commitment every month helped me build lifelong relationships with peers and mentors and increased my knowledge and skills. I often say the single best return on investment for my career has been my DIA membership.

BIOGRAPHY

Munish Mehra, PhD, MS, serves as Principal Biostatistician and Executive Director at Tigermed. During a career spanning over 30 years, he gained extensive experience in the design, analysis, and reporting of phase I-IV clinical trials across multiple therapeutic areas, including drugs or biologics for neurology, oncology, dermatology, cardiovascular, metabolic and endocrine, respiratory, GI, vaccines, and women’s health. Mehra has held positions of increasing responsibility at multiple CROs in the US, has founded a SMO and CRO in India, and expanded CRO operations for a US CRO in China. He has represented sponsors at FDA Type B pre-IND, end of phase II and pre-NDA as well as Type C meetings as an expert biostatistician. He has developed IDMC charters and supported IDMC’s as unblinded biostatistician. He currently serves on several DMCs. Mehra was awarded the DIA Global Inspire Excellence in Service Award at the 2018 DIA Annual Meeting. He currently heads the DIA Clinical Research Community and is actively involved on the biostatistics and GCP core committees. He has also authored numerous publications in peer-reviewed journals and presented at numerous conferences. Mehra holds a PhD in biostatistics, a MS in computer science from the University of Kentucky, as well as a MS in mathematics from the Indian Institute of Technology.