Navitas Data Sciences’ Director of Biostatistics, Sanjay Mitter lives by the Claude Bernard motto: “Man can learn nothing unless he proceeds from the known to the unknown.” Indeed, Mitter has spent the bulk of his life and career forging ahead, exploring, learning, and embracing new ways to serve humanity. “I am passionate about learning various therapeutic indications that serve humanity and are dedicated to developing core competencies globally toward that goal,” he says.
We were interested in learning what insights Mitter can offer us from his position working on COVID-19 projects. “I am currently working on a Phase 3 trial with a monoclonal antibody drug, invariably, couple of challenges had to be quickly overcome: Reaching recruitment targets and Expedited Trials Using Complex Innovative Designs & Real-World Evidence. These were mitigated through utilization of Advanced Analytics which included dynamic borrowing from previous trials using validated Bayesian methods to simulate enrollment without the need to use scarce patients.,” he said in response to our inquiry. His interests and focus have much to do with the patient and that foundation explains his journey in medicine.
Navitas Data Sciences’ Director of Biostatistics, Sanjay Mitter
Mitter earned a B.S. in Mathematics and Statistics from Delhi University, Delhi, India in 1985, followed by an M.Sc. in Applied Mathematics, Computer Science from India's top technical school, the Indian Institute of Technology, Delhi in 1987. Two years later, an M.Sc. in Statistics at Concordia University, Montreal followed, giving him a strong foundation on which to build his illustrious career. His work has taken him from India to Canada, then Switzerland, and finally to the U.S. where he now resides in New York State.
We also asked Mitter: “Considering how much Big Data is at play these days, are there similarities in the Biostatistician and Bioinformatician roles?” He responded: “The advent of Big Data and AI, in which we have unprecedented access to an avalanche of information, can change forever how well we, as a society, manage our health. This is where the incorporation of computer science and information technology with molecular biology is so analogous to Biostatistics (integration of statistics with Biology).” (Mitter has a Master’s in both these fields which helps him apply computing algorithms like Neural Network, Bayesian Analysis to real-world biological challenges.)
He entered the industry in 1992 as a Senior Biostatistician in Oncology drug development at Ciba-Geigy. In addition, as a lead statistician, he has held notable industry positions as Vice President and Global Head of Clinical Research Services at QPS, Delaware; Global Director of Biostatistics, Data Management (Opioid Addiction and Schizophrenia) at Reckitt Benckiser, Virginia; Senior Director (Medical Device) at Allergan, California; Director (Oncology and Medical Device) at Novella Clinical (a Quintiles Company), North Carolina; Global Head, Analysis and Reporting (Oncology) at PRA International, British Columbia; Director (Oncology, Arthritis) at Regeneron, New York; Drug Safety Scientist at Roche, CH; Associate Director (Cardiovascular) at Pharmacia, Illinois; and Manager (Vaccines) at Sanofi Pasteur, Ontario.
During his distinguished career, Mitter has amassed over twenty-eight years of global experience in Clinical Biostatistics and Statistical Programming (R&D), including representing the sponsor company to the FDA/EMA/cFDA and other regulatory agency meetings. A few of the prominent accomplishments that have resulted in approvals include the Sanofi Pasteur Pediatric vaccine DAPTACEL®/PENTACEL®; the Pharmacia Hypertension drug INSPRA®; the Roche Obesity drug: XENICAL®; the Indivior Opioid Addiction drug SUBUTEX®/SUBOXONE®; the Indivior Schizophrenia drug PERSERIS®; and the Allergan medical device LAPBAND®.
At Novella Clinical (a Quintiles Company), Mitter led a team for a TULSA-PRO medical device, and at PRA International, he worked on evaluating Quality of Life and Patient-Reported Outcomes (PRO) for the Medical Business Operations Oncology (pegfilgrastim, panitumumab) group. Mitter was also Lead Statistician for the multi-national, multi-center Phase 3 clinical study of FP-001 LMIS 50 mg (a 6-month formulation) for the treatment of advanced prostate cancer.
Mitter played an important role in the development and FDA Approval of (CDRH) LAPBAND for lower BMI. As Lead Statistician, his responsibilities included overseeing statistical and data management activities, including statistical analysis plan development, database specification, reporting specification, statistical programming analysis, and statistical summary and report writing.
As Lead Statistician for the FDA EOP 2 meeting with the Division of Psychiatry Products, Mitter provided the Agency with an update of the product development program for RBP-7000 for the treatment of Schizophrenia. This proved to be a particularly challenging assignment, in which Mitter was tasked with providing the Agency with an update of the product development program for RBP-7000 for the treatment of Schizophrenia. “The work project was challenging due to the difficult patient population and I had to apply innovative designs for imputing missing values (utilizing MMRM methodology),” Mitter remembers. Ultimately, his diligence contributed greatly to the FDA approval of the investigational product.
Mitter joined Navitas Data Sciences/ DataCeutics a year and a half ago and it has been a fruitful partnership for both parties. Mitter appreciates the common goals and values he shares with Navitas. “I enjoy working in collaboration with great thought leaders who have a strong vision and core values,” he says. And in this wonderfully symbiotic relationship, the company is delighted to have the benefit of his vast experience, his thoughtful demeanor, and his worldly wisdom among their ranks. Mitter is known for always seeing things from a broad spectrum and embracing growth and development with a keen eye for what will ultimately benefit mankind as well as the company.
As one can imagine, such a hard-working, career-oriented individual has little time for recreation, but Mitter does enjoy staying in shape by swimming and playing tennis. His presentations and participation at industry conferences and important meetings are too numerous to list here, but it is important to note some of his well-deserved accolades:
Graduate Fellowship granted by Concordia University, 1987 – 1989
Graduate Fellowship granted by Dalhousie University, 1989 – 1990
Killam Fellowship granted by Dalhousie University (Award for Best Ph.D. level Graduate Student), 1990 – 1992
Network of Center of Excellence Award for developing Epidemiological Models with Public Health Applications, University of Toronto (with Sanofi Pasteur), 1998 – 1999
Mitter’s passion for medicine has made a great impression within his lovely family. His daughter, Karishma, is now studying at the School of Dental Medicine following her dad’s footsteps. The world needs people like Sanjay Mitter, who are willing to devote their lives to the benefit and survival of humanity. His devotion and willingness to push the boundaries of the known to the unknown should be applauded and emulated. Bravo!