– Written by Binoy Varghese, AbbVie, Director & Head, Statistical Programming Operations & Safety Statistical Programming
Binoy is a visionary leader capable of driving operational and technology initiatives from conception to execution. He is an out-of-the-box thinker with an excellent track record of leading cross-functional teams, nurturing strategic partnerships, and facilitating operational excellence. As an effective communicator, he is adept at influencing and engaging audiences at all levels across the business.
At AbbVie, Binoy is responsible for the Statistical Programming Operations and the Safety Statistical Programming functions within the Statistical Reporting & Standards organization. He joined AbbVie in 2020 to spearhead the Statistical Programming Operations function before transitioning to his expanded role in 2023. In his current position, he serves as the custodian of integrated product safety databases that enable continuous safety surveillance and periodic safety reporting to regulatory agencies. Additionally, he oversees the strategy and execution of infrastructure modernization, process automation, and operational excellence within the Statistical Reporting & Standards organization.
Before joining AbbVie, Binoy worked in various capacities within the Pharma-Biotech industry for over 20 years. His experience spans a spectrum of companies, including Abbott, AstraZeneca, Pfizer, and Novartis, among others. He has presented at numerous industry conferences and is a member of the North American Pharmaceutical Innovation Heads Council.
Binoy earned an Executive M.B.A. from the Quantic School of Business and Technology, an M.S. in Computer Science from California State University, Chico, and a B.Eng. in Computer Engineering from the University of Mumbai.
1. What attracted you to your current position?
What attracted me to my current position as Head, Statistical Programming Operations & Safety Statistical Programming was the unique opportunity to lead teams at the forefront of technological innovation in the statistical programming space. The role allows me to combine my expertise in statistical programming with my passion for driving advancements which improve operational efficiency and ensure patient safety. I was particularly drawn to the challenge of integrating complex data at the product level to monitor safety signals, as it requires both strategic thinking and technical expertise. The ability to shape future-ready technology infrastructure and contribute to business-critical analytics made this position an ideal fit for my skills and career aspirations.
2. If you could offer one piece of advice to someone just starting out in the pharmaceutical industry and another to someone well established in their career, what would they be?
For those just starting out, my advice is to stay curious and continuously expand your knowledge. Statistical programming is constantly evolving with advancements in technology and regulations. Embrace lifelong learning, be proactive in understanding both business and technology beyond your immediate role, and seek mentors to navigate the field’s complexities.
For those well established, remain adaptable and open to change. The rapid pace of innovation demands not only expertise but also the ability to pivot and embrace new approaches. Use your experience to lead and mentor, while staying open to learning from emerging trends and technologies reshaping the industry.
3. How would you describe your leadership style in just a few words?
I would describe my leadership style as a blend of collaboration, strategic insight, hands-on involvement, and empowerment.
4. If you weren’t doing this job, then what would you be doing?
If I weren’t in this role, I would likely be involved in technology consulting or innovation management. I’m passionate about leveraging technology to solve complex problems, and these fields would allow me to continue driving impactful change across industries.
5. Reflecting on your career journey, what professional achievement are you most proud of, and how has it shaped your approach to leadership and innovation?
The achievement I’m most proud of is leading the implementation of advanced solutions that transformed an end-to-end submission pipeline. It improved efficiency and set new standards for quality. This experience shaped my leadership by reinforcing the value of innovation, collaboration, and empowering teams to embrace cutting-edge solutions while staying focused on business goals.
6. Can you share a challenging decision you’ve had to make recently and how you navigated it?
Recently, I had to choose between pursuing a high-risk, high-reward technology initiative and a safer, more immediate project. I opted for the innovative route, believing in its potential for long-term impact. I navigated the decision by consulting with stakeholders, conducting a thorough risk assessment, and adopting a phased approach to balance innovation with manageable risk. This allowed us to pursue bold advancements while maintaining alignment with our strategic objectives.
7. In what ways do you see the pharmaceutical industry evolving in the next decade, and how are you preparing for those changes?
Over the next decade, the pharmaceutical industry will become increasingly data-driven, with advancements in AI, machine learning, and personalised medicine transforming drug development and delivery. To prepare, I’m focused on staying at the forefront of emerging technologies, latest regulations and fostering innovation within my teams, so we are ready to adapt to these changes and leverage them to improve patient outcomes.
8. What do you think about the shift in programmer input being included earlier in study design over the years?
I believe the shift towards including programming input earlier in study design is a positive and necessary evolution. Programmers bring a deep understanding of data structure, analysis workflows, and potential automation opportunities, which can significantly enhance study design from the outset. By involving programmers early, we can anticipate data-related challenges, streamline processes, and ensure the study is both scientifically sound and operationally efficient. This collaborative approach leads to more robust study designs and accelerates the path to insights and regulatory submissions.
9. What is your ideal balance for sponsors and contract research organisation (CRO) functional service provider (FSP) resources to work well together on programming teams?
The ideal balance between sponsors and CRO/FSP resources involves clear communication, aligned goals, and complementary expertise. Sponsors should provide strategic direction and maintain oversight, while CRO/FSP teams offer specialised skills and executional support. Success depends on establishing strong collaboration, with both parties working as a unified team, sharing knowledge, and maintaining transparency throughout the project. This balance ensures efficiency, quality and alignment with the overall objectives of the study.
10. How can the industry avoid programmer resource turnover and knowledge loss?
To avoid programmer turnover and knowledge loss, the industry should focus on creating a supportive and growth-oriented work environment. This includes providing ongoing training and development opportunities, fostering clear career progression paths, and ensuring work-life balance to prevent burnout. Additionally, implementing strong knowledge management systems – such as documentation, cross-training, and mentorship programmes – can help preserve expertise within teams and ensure smooth transitions if turnover occurs. By investing in both employee retention and knowledge sharing, the industry can minimise disruption and maintain continuity in critical programming functions.
Disclaimer: The opinions expressed in this article are solely my own and do not reflect the views or opinions of my employer, colleagues, or any organisations I am affiliated with. The content provided here is for informational purposes only and should not be considered professional advice.
