Disclaimer 

The views and opinions expressed in the interview are those of the individual interviewee and should not be attributed to any organization with which the interviewee is employed or affiliated.

Quantifying the safety, efficacy and effectiveness of a new drug to determine its overall benefits to the general population is probably the most significant hurdle in launching a newly developed medicinal product in the market.

Biswajit Sen, our next pathbreaker, Lead BioStatistician at Novartis, designs multiple clinical trials for specific population demographics, aligned with the overall development plan of the medicine, providing statistical expertise including analyses which are unique to the population.

Biswajit talks to Shyam Krishnamurthy from The Interview Portal about taking the opportunity to fulfil his ambition of working in a field where he could apply his expertise in biostatistics to the pharmaceutical industry through development and approval of new drugs that benefit patients

For students, this is your opportunity to be a part of a diverse team of doctors, programmers, data managers, operation team members, and drug manufacturers with the common goal of driving drug development for greater good !

Biswajit, tell us about your background?

If I look back to see where I have spent my last 5.5. years in the Pharmaceutical Industry, here is a small snapshot –

Three of the medicines on which I worked as statistician, got approval in Europe and other countries, Enerzair: a triple combination for asthma, Atectura: a double combination for asthma, Leqvio: which reduces LDL or bad cholesterol. I got opportunities to work on 7 different medicines, +20 clinical trials, 2 publications, +30 workshops or presentations. I have also conducted 5 workshops in different states of India interacting with +500 doctors, medical students. I have received more than 20 internal awards including 3 promotions, one outstanding performance award from NIPER  Hyderabad. I became one of the top young leaders globally with social impact in my company, and got chances to work for underprivileged section of society. 

My journey started from a small room of a middle class family in Kolkata, West Bengal. In that room there was a small rectangle shaped poster hanging on the wall. It had a picture of a valley fully covered with snow and snow-clad hills. For a five year old boy, that was like a dream country; and this is my journey in transforming that dream into reality. 

Both my parents couldn’t complete their schooling due to financial challenges, but they always wanted to give their elder son the best institutional education that they could think of. Hence, I started my schooling from Baranagar Ramakrishna Mission Ashram High School, an institute where my teachers not only gave me education, but also shaped my vision for the rest of my life. 

Since childhood, I always loved writing poems, a few of them also got published in school magazines. I have learnt painting for more than ten years. One day in my painting class, when I complained to my teacher as to why I have not received a better painting book to take some inspiration from; he told me that everyone could imitate a beautiful picture, hence I should try to create something beautiful which will inspire others. I have tried to carry those few words from my painting class to each and every corner of my life; and that is my inspiration.

What did you do for graduation/post graduation?

After completion of my higher secondary, I took admission in Ashutosh College for B.Sc. degree in Statistics, after getting rejected from many colleges in Kolkata. Interestingly, after three years, I got my B.Sc. degree from Calcutta University securing 2nd rank among all students, including students from one of the colleges from where I was rejected earlier. 

After graduation, I got selected via competitive examination to study in Indian Statistical Institute (ISI), Delhi, one of the best institutions in India if someone wants to pursue a career in Statistics. I was also invited by IIT Kanpur to take admission in M.Sc. after securing All India Ranking (AIR) – 21 in IIT JAM entrance examination. But I chose ISI. I studied 1st year of my Masters in Statistics (M.Stat.) degree in Delhi center and my 2nd or final year in Kolkata center in Biostatistics(specialization). For more information on academic programs, admission procedure of ISI, please visit their official page.

What made you choose such an offbeat, unconventional and unusual career?

I always had a keen interest in Biology and wanted to be a scientist in that field. But during the first month of Class XI, when I visited our family doctor after getting sick, he suggested that I should consider studying statistics which is a very interesting subject and not so common (at that time). After a few google searches, I changed my subject from biology to statistics and decided to pursue a career which will be a bridge between these two fields. And the pharmaceutical industry was that bridge for me.

How did you plan the steps to get into the career you wanted? Or how did you make a transition to a new career? Tell us about your career path

I joined my current company which is one of the top multinational pharma companies, after completing my post-graduation in 2015. Though I studied biostatistics as my specialization, the transition from academics to industry was not easy for me. Being an introvert, it was like a whole different world to me, starting from how to talk to colleagues to understanding each and every step of drug development including the procedures. I even didn’t know the software we use (e.g. SAS) to analyze data. But every unknown thing gave me the opportunity to thrive by knowing more. I have tried to utilize all the opportunities that have come in front of me.

I still remember the time when I joined as a junior Biostatistician. My first task was to calculate the sample size of a few studies under a project. After one month, I got assigned as trial statistician for one of the Phase III studies in the respiratory franchise with the responsibility of protocol writing, statistical analysis plan, table-figure-listing, and clinical study report preparation. During that time, I learnt the key points that we should keep in mind while designing a trial, how to set up clinical trials, how to collect data, how to prepare raw data for analysis and how to interpret statistical results at a level where a non-statistician will understand the interpretation. 

With time, as my responsibilities increased, my designation also got changed. In general, drug development includes 4 phases of clinical trials and in Phase III we conduct trials to confirm the benefit of the drug and then we proceed to receiving approval of health authority if the results of the trial are positive. I have mostly worked in these types of Phase III trials throughout my career, but also got opportunities to work in post-marketing studies of Phase IIIB, pediatric studies of Phase II/IIB, drug safety related document updates (e.g. PSUR, DSUR, RMP & others). For first couple of years, I have worked under guidance of senior statisticians but as I gained experience, I started working more independently in my assignments.

When I was Principal Biostatistician, I worked as Lead Safety Statistician whose responsibility was analyzing safety data coming from multiple clinical trials of the same drug and support health authority (HA) approval. Few of those documents are Summary of Clinical Safety (SCS), Risk Management Plan (RMP), Adverse Drug Reaction (ADR) etc. I also supported statistical line functions to answer questions from multiple health authorities e.g. EMA, FDA, SwissMedic etc. on market authorization application in Cardiovascular Franchise. A Marketing Authorization Application (MAA) is an application submitted by a drug manufacturer seeking permission to bring a newly developed medicinal product (for example, a new medicine) to the market.

Simultaneously I have worked on many initiatives either in a local team or representing India in a global team. Few of them are: Implementation of HA guidelines with responsibility of conducting awareness programs, training etc.; working with the Advance Visualization Analytics team to strengthen the data visualization in Pharma. Currently I am a core team member of Output Governance Board in my company, ensuring consistent structure of the outputs across all drug development units.

How did you get your first break?

In 2015 during my 4th semester of M.Stat.Degree, a few colleagues of my current company were conducting a statistics workshop in ISI, Kolkata. At the end of the workshop they asked if anyone wants to join their team. And I saw the opportunity to fulfil my dream of working in a field where I can use my biostatistics knowledge as well as be close to biology (medical field). Hence I shared my CV with them. After a small telephonic interview, I travelled to Hyderabad for an in-person interview (BTW that was my first travel by air). What I liked most about the interview was that it was focused on what I knew rather than what I didn’t know at that time. Approximately two months after the interview, I joined my company as a research biostatistician. I was the youngest member of the biostatistics team.

What were the challenges you faced? How did you address them?

Since i was coming from academia, the first challenge I faced after joining the pharmaceutical industry was that I didn’t know much about drug development procedures and there were lots of operational tasks that were associated with my job role as trial statistician. I used to read as many documents as I could, e.g. clinical development plan, study protocol, analysis plan, clinical study reports to understand what were the similarities or differences among them, how analysis plans had been written, how the results had been interpreted. For me, the most important thing was to understand what was written, rather than just brushing over the pages.

Another challenge was communicating statistical concepts or results to non-statisticians. We biostatisticians are part of a diverse team of doctors, programmers, data managers, operation team members, and drug manufacturers. Hence whenever we are discussing any statistical topic with other team members, we have to share that in such a way that everyone can understand what we are saying. And that comes with practice. The more you discuss with a non-statistician, the more you will learn. And in my company we conduct statistical workshops for non-statistician colleagues. I joined that workshop as a trainer after joining the company. Since then, I have seen tremendous growth in myself year by year.

Third challenge for me was that I didn’t know SAS, the software we use to analyze data. I have learnt R in my college but not SAS. But it was not that difficult to learn because whenever I saw any draft SAS codes in any analysis plan that I didn’t know before, I used to save them and then tried to apply them in my study data just to see the results I was getting. I think we just have to be a little experimental to learn new things.

Though there were challenges, I was fortunate enough that I got many opportunities to grow and learn; had many colleagues who not only helped me whenever I got stuck but also took care of me whenever I got sick or needed any help; I had managers who were my guides. Without them, I couldn’t have come so far and most importantly I made few good friends along the journey.

Where do you work now? What problems do you solve?

Currently, as Senior Principal Biostatistician, I am working as Lead Statistician of pediatric indication of cardiovascular medicine to make this medicine available for patients of less than 18 years of age. Working in trials which include younger patients is a slightly different experience compared to trials with adult patients. In this case, we not only have to ensure the safety of the young kids, including their growth & development, but also need to recruit young kids in trials, which becomes very challenging because either such diseases are rare in children or parents are unwilling to permit their children to participate in trials. Hence often we need to use some advanced statistical methods or analyses which are unique to pediatric trials.

My responsibilities as Lead statistician are designing multiple clinical trials for young kids, aligned with the overall development plan of the medicine, providing statistical expertise including analyses which are unique to young population, interacting with multiple health authorities to meet their requirements to receive marketing approval and so on. Most of the time, I go through many publications on medicines that are already approved for the same disease (or sometimes in other disease) to understand which analyses were required and how they have analyzed data. In general, I believe in drug development as much as you observe what is happening beyond your own project and learn from other’s experience. Then you are more prepared for your own assignment.

I am also serving as Lead Safety statistician looking after the annual safety updates (PSUR, DSUR, RMP & others) of medicine, and as Lead DMC (data monitoring committee) statistician, I engage in discussions with DMC members, internal teams and our external partners regarding development of DMC charter, requirements for analyses, and guide trial statisticians to write analysis plans, mock shells.

I am also a member of the extended Biostatistics leadership team in India, and I share my thoughts with the leadership team regarding multiple initiatives for betterment of our team and helping our team members to achieve their goals. I am also one of the mentors in “reverse mentoring” program where I share my perspective with a couple of members from the senior management team, while learning from their experience in subjects like Leadership trends and expectation, technological & digital advances, ESG and business innovation.

What I like the most about my job is that I am working to make people’s life better, which is one of the purposes of my life. I am getting the opportunities to grow professionally and to push my boundaries every day to become drug developer of future.

How does your work benefit society? 

I am in the pharmaceutical industry and patients are at the center of our drug development journey. There are many diseases where there is no medicine available till now, and each and every day we try our best to find solutions to ease the disease burden of those patients. When I see the news of regulatory approval of a medicine that I had worked on for almost five years, that is the best reward of all the hard work.  

Being biostatisticians, we are at the heart of drug development. We, along with other team members, design the clinical trials, decide the number of patients needed in the trial, analyze the data and interpret the results. One of the major requirements of any drug approval is achieving statistical significance in the trial and as biostatistician, our responsibility is to guide the team and inform them on how we can fulfil the requirements from a statistical point of view, to achieve the goal. Hence, becoming a biostatistician, you can actually see how you are driving drug development as key contributor and how your work directly benefits the society on a large scale.

Also, as part of the initiative of giving back to society, I travelled to many cities in India to conduct statistical workshops for Oncologists. Till date, I have interacted with more than 500 Oncologists and medical students all over India. I am also a council member of the CSR team of my company in India and am leading a couple of mentorship programs along with NGOs, which provide training on soft skills to students hailing from socio-economically weak backgrounds.

Tell us an example of a specific memorable work you did that is very close to you!

There are many works that are memorable to me, but I will tell you a recent one that is close to my heart. This year I have been recognized as one of the top young leaders (< 30 years age) with social impact in my company and will represent my company in One Young World 2021 summit in Germany. 

Brief summary from OYW official page, “The annual One Young World Summit convenes the brightest young talent from every country and sector, working to accelerate social impact. Delegates from 190+ countries are counselled by influential political, business and humanitarian leaders such as Justin Trudeau, Paul Polman and Meghan Markle, amongst many other global figures.”

I am thrilled and excited to represent my company and my country in the global forum where I can share my story and learn from other young and global leaders to make this world a better place. After all, today is the reality of the imagination of the previous generation, and it is our duty towards the young generation to help them reimagine their future.

Your advice to students based on your experience?

My first advice to students is, please focus on your studies and try to learn as much as possible, which will develop the habit of giving attention to each and every detail of the work that you will be assigned in future. Also please try something new whenever you get some time off, it may be pursuing a new hobby, or expanding your boundaries. This will certainly be helpful in adapting to a rapidly changing workplace. My last advice will be to choose a career that you like. Only if you love your job, you can sustain for a longer time with a smile of satisfaction. 

Future Plans?

I am currently working on myself to polish my leadership skills so that I can empower others to achieve their goals. I am also planning to pursue some finance related course or medical course, at least some online courses to learn new things. And for those who have any queries related to statistics, or you want to know more about my job in details, please connect with me via linkedin https://www.linkedin.com/in/biswajit-sen-070a638b/

BTW, the dream country in the small rectangular poster that I was talking about at the beginning was Switzerland; the country I visited in 2017 as part of my first international business trip. And today, I will stop here with one of my favorite songs from The Prince of Egypt, “Who knows what miracles you can achieve; when you believe, somehow you will”.