Every dose of medication taken in by patients, whether it is for cancer or diabetes or regular fever, has a story to tell ! A story of survival through multiple phases of fundamental research, drug development, clinical trials, regulatory hurdles and market entry. Very few drugs make it to the counter and in the hands of those who need them.
Today we talk to one such pathbreaker, Biostatistician, Tuli De, who talks to us about the role of a Biostatistician in this long and laborious drug development and approval process and what makes her work so satisfying.
Shyam Krishnamurthy from The Interview Portal talks to Tuli De about her career as a BioStatistician and transition from academics to the industry.
Hi Tuli, can you tell us about your background?
I spent my early life in Kolkata, West Bengal. My father is an emeritus professor of English and my mother studied Bengali literature and is a home maker. Right from my childhood I was naturally curious, and wanted to explore and know about almost everything. My interests varied time to time but I always wanted to learn new and challenging things.
What did you study?
I did my graduation from St. Xavier’s college and then my masters and Ph.D. in Statistics from University of Calcutta.
How did you end up in such an offbeat. unconventional and unusual career?
My career is a mix of academic and industry experience. I opted for statistics as I liked playing with numbers from the very beginning. The key influence to choose an academic career was my father. He was a professor, and thus I wanted to become a professor of statistics.
I cracked the national eligibility test and qualified for research fellowship. I pursued my career as Assistant professor. I started my doctoral work in Astrostatistics and continued to work as a research fellow, I published seven papers in peer reviewed high impact factor international journals.
Among them one of the publication was the Winner of “Outstanding contribution of Astrostatistics publication student award” in IAA —”International Astrostatistics Association”.
If you would like to view the entire list of publications, please check out my LinkedIn profile-
However, something was missing. After spending few years in academics, I realized that I liked the research part more than teaching and wanted to opt for a profession which will give me extensive research experience.
I wanted to pursue a career in statistics and at the same time wanted to do something broader and wanted to relate my work with the direct benefit of society and surroundings. Rather than having a fixed career goal, my aim was to keep exploring and throwing myself into newer challenges. I always wanted a career which will give me opportunity to learn new things.
After careful considerations, I realized, the only way I can contribute to society through my area of expertise is to join the healthcare domain. And hence I left the teaching job and joined a Pharmaceutical company as a Biostatistician to satisfy my willingness to explore the clinical domain. The Biostatistics domain gives enormous research opportunities to statisticians in the research and development wing. I finished my PhD work and earned my doctorate degree in Statistics in the meantime.
Tell us about your career path
The turning point in my career came when i joined the Biostatistics domain from academics. The profession is unconventional, however, but gives you tremendous satisfaction of being a part of drug development to marketing of a new medicine and hence your work benefits thousands of people.
I started as a fresher in a big Pharma company. Though i had no prior experience regarding clinical trials and drug development, luckily enough with my academic expertise, i was placed in a submission project in an Oncology full development program. Full development projects give you the breadth of learning on the end to end drug development process from human studies to health authority submission. I continued learning many things and contributed a lot in designing new trials, protocol development, fixing minimum number of patients in a trial, determining the optimum doses, endpoint related analysis based on statistics etc. My career path took an accelerated turn when I was placed in another submission project in Oncology and lead many parts of that project. In 4 years of my career with that company I was promoted from a fresher Biostatistician to a principal statistician and held accountability for almost every aspect of a clinical trial.
However, after spending 4 years in Pharma, I decided to broaden my area of expertise and among several other companies who reached out to me at that point of time, I joined a globally leading CRO as a Biostatistics lead. The role of a Biostatistics lead had a wide coverage in CRO industry, The lead is responsible for all Biostatistics and programming related deliverables and the one stop point of contact for clients.
What were the challenges?
The major challenge when I transitioned from academics to Industry was the hours of work that a corporate job demands. Academic and research environments are relaxed, it gives you the freedom and time of explore new things.
It was harder for me as I started working in a drug submission project. As this was a health authority submission, it required additional effort and additional hours. However, I started liking my work. In the midst of the work pressure and challenges, I noticed that I was learning a lot of new things and my growth was really steep. Thus I was able to overcome my first challenge.
My next challenge was to try to go beyond project level responsibilities and contribute to building a functionally strong Biostatistics team. I started conducting trainings for statisticians and other line functions, collaborated with academic institutes to bring interns and projects into the company. The challenge was to motivate fellow colleagues to take out time for functional development and also to convince academic institutes that collaboration with us can really make a difference. However, with extensive team work, we were successful in most of the ventures.
The third challenge was again transitioning from Pharma to CRO for horizontal growth. My role was very broad there, leading statistics projects for multiple therapeutic areas, participating in Client proposal meetings and mentoring people in the team. It required lot of time and motivation. I met so many local and global clients and was able to build a strong network and reputation.
Can you tell us the role of a statistician in Clinical Trials?
A statistician’s role in trial design starts from development of initial structure of trial design, fixing the patient population, calculating sample size. The statistician is one of main stakeholders in Clinical Trial Protocol development and determining the statistical analysis related to that trial in order to claim the trial as successful or unsuccessful. Statistician authors several documents in clinical trial, and critically reviews the ongoing trial data. Statistician produces/reviews key results of trial and finally those results are submitted to health authority for drug approval. Statistician also performs analysis for Health authority questions, conference presentations and publications of trial results. Finally, statistician reviews the clinical study report which files all details of trial with statistical results and interprets the results and statistical implications. Finally, with clinical and statistical interpretation, a trial is declared successful or unsuccessful based on which a decision is made on release of the drug in the market after crossing all other hurdles.
What are the skills needed for a Clinical Statistician?
I think apart from having an extensive statistical knowledge, you need to have a clinical eye, a detailed understanding of the therapeutic area and skilled at different statistical programming languages such as SAS, R etc.
The required skills comes with experience. As you learn and grow and if you have a passion for your role, the skills will be acquired automatically.
A typical day in life of a CRO statistician is busy, packed with deliverables, client consultancy and leading the team under you.
I love being a thought leader and a solution provider . A statistician is required to resolve any issue while study conduct. And here comes the authority and accountability which I like the most about my job
How does your work benefit the society?
Healthcare itself brings benefits to society and being a healthcare professional associated with end to end drug development brings new medicines into the market, reaching out to millions of patients and benefiting the society in enormous way.
Tell us an example of a specific work you did that is very close to you!
I have worked in many clinical trials and submission projects. Among them, I was leading many areas of an Oncology drug submission project. With my statistical expertise I was able to lead many difficult health authority approval challenges and the Oncology drug was finally approved by the health authority. It was a long journey and it was the first in line of therapy of untreated patients of Acute Myeloid Leukemia which was a tremendous achievement for myself and the entire team.
What do you do currently?
I have recently moved to California and trying to work as an independent consultant and solution provider for Biostatistics and statistical programming. It’s a whole new venture and my aim is to spread general awareness about importance of statistics in healthcare. I am waiting for the permit to come and while waiting for the permit, i have started publishing articles in LinkedIn and started my own statistics and healthcare blog.
Prior to starting this new venture, I was associated with a global CRO till the month of October. I worked as a Biostats lead who provides consultancy to trial design, sample size calculation, protocol and SAP development, data critical review and production of Statistical analysis reports, analysis for health authority submission, conference and paper publications. Actually a statistician has end to end involvement starting from designing of a trial till drug launch in the market.
Iam also working as a Senior Researcher with MUST Research, to promote excellence and competence in the field of data science, cognitive computing, artificial intelligence, machine learning, advanced analytics for the benefit of the society. My primary responsibility is to do research and to build an ecosystem to enable interaction between academia and enterprise, help them in resolving problems, as well make them aware of the latest developments in the cognitive era on scientific programs and societal missions. MUST Research is a non-profit organization registered under Society and Trust Act of India.
Your advice to students based on your experience?
The only advice or rather suggestion I have is to follow your passion. If you target to achieve excellence, success will follow you and you don’t need to chase it!
I am trying to establish my independent footsteps in the healthcare industry. I will work as consultant, solution provider and spread general awareness regarding Statistics and Healthcare. I have already started the initiative by publishing articles in LinkedIn to motivate students, freshers and all healthcare professionals.
Please check out the following links-