Inference Inc. was founded on the belief that there is a need for quality biostatistics and data management services in drug development. Our operations are anchored in our deep experience in supporting a variety of development programs at the portfolio level, as well as expertise in support of individual studies. We translate trial objectives to testable hypotheses, develop optimal study designs, and formulate best analytical strategies for reporting the data. Our understanding of the science and the ever-changing regulatory expectations worldwide is reflected in how we collect clinical data, maintain integrity of the trial, and finally how we make statistical inference. After all, accurate clinical conclusions must rest on flawless execution and reporting of the data.
- Headquartered in Chesterbrook, PA
- Two offices, more than 55 professionals
- Debt-free, privately held
- Supports Phase I-Phase IV trials
- Combined management experience of over 125 years
- Completed more than 50 studies in last 3 years
- Combined experience of working on 1000+ studies.
- Project-based and Functional Service Provider (FSP) model
Chief Executive Officer
Kalyan is the Founder and Chief Executive of Inference Inc. With over 25+ years of experience in clinical biostatistics managing all phases of drug development, he brings a wealth of experience from his years in both big pharma and CROs. He has spent 13 years at Merck (in both early & late phases) and 4 years at BMS (late phase). He has led multiple regulatory filings for drugs and biologics with agencies world-wide. He also founded Vislation, a boutique CRO supported by Merck Capital Ventures, and which is now part of Cytel.
Kalyan serves as an expert statistical reviewer for several journals including The Lancet. Previously he was a member of the executive committee of the biopharmaceutical section of the American Statistical Association.
VP, Client Engagements
Mark serves as Vice President of Client Engagements managing ongoing sponsor relationships as well as generating new ones. Mark has 20 years of experience in data management operations and in building solution-focused strategies and operating models. Before Inference Mark was Unit Head for the Clinical Data Management Department of Translational Clinical Oncology at Novartis Pharmaceuticals. Mark has an MBA from Lehigh University in Bethlehem, PA and an honors bachelor’s degree in biochemistry from the University of Toronto, Toronto, Canada.
VP, Data Management
Indrani brings over 18 years experience in Data Management working in CRO and Pharmaceutical industry such as Inventiv Health (currently Syneos), Pharmanet, BMS and PPD. Indrani is responsible for overseeing a team of clinical data managers and database developers in order to meet operational targets and ensure quality and accuracy of data. She also trains and mentors the data management team. Indrani has experience in all Phases of drug development and has worked in all therapeutic areas mostly specializing in Oncology, Neuroscience and Autoimmune Disorders. Indrani has a Master’s degree in Nuclear Biochemistry.
Chief of Staff
Tanusree serves as the Chief of Staff helping Kalyan make day-to-day decisions for Inference. She manages timely preparation of sponsor deliverables, as well as ensures operational aspects of the business are robust. She is a certified SAS programmer and responsible for overseeing the programming of pharmacokinetic analyses. Before co-founding Inference with Kalyan, she worked as a statistical programmer at WCCT Global. She has a Master’s degree in Philosophy from University of Calcutta.
Sr. Director, Statistics
Lisa is Senior Director, Statistics at Inference Inc. With over 19+ years of experience in clinical biostatistics managing all phases of drug development, she brings a wealth of experience from her years in both big pharma and CROs. Lisa has experience in all phases of drug development, navigating both the technical and regulatory domains. Before joining Inference, she worked at Teva, where she managed the Phase I group. In 2007, along with Kalyan she also founded Vislation, a boutique CRO providing biostatistics support to pharma companies.
Sr. Director, Project Management
Anuja serves as Sr. Director of Project Management & Quality. She has over 16 years of experience in managing large programs and geographically distributed cross-functional teams for development, maintenance, re-engineering and migration of projects. At Inference she is also responsible for budgeting, forecasting and invoicing. Before Inference Anuja worked as a senior IT manager at Cognizant and Tata Infotech. She has a degree in Architechture from Jadavpur University.
Director, Business Processes & Recruitment
Michelle serves as Director of Recruitment managing ongoing biometric staffing relationships as well as generating new ones. Michelle has over 20 years of experience in data management, data standards, quality assurance and governance. Before Inference Michelle was Head of Oncology Data Standards for the Oncology Clinical Data Management Department at Novartis Pharmaceuticals. Michelle has her bachelor’s degree from Ursinus College, Collegeville, PA and is a Certified Clinical Data Manager (CCDM).
Anindita’s responsibility includes managing operations including statistical programming. She is a seasoned statistical programming manager with over 16 years of experience in delivering projects for global sponsors. She is a certified SAS programmer. Before joining Inference Anindita worked at Cytel and Novartis. She currently mentors the programming staff. Anindita has a Master’s degree in Statistics from Pune University.
Director, Business Development & Marketing
Junko serves as Director of Business development and Marketing, identifying business opportunities, expanding relationships with sponsors and as well as serving as a liaison between Inference and sponsors. Prior to joining Inference, she was a marketing assistant for a Japanese chemical company. In this role, she handled SNS marketing, in-person events as well as working as a liaison between the foreign executives and local managers. Her passion is to help and serve others to realize the blind spots and to bring them to the next level in business and/or personal life. She lived in Japan half of her life and the other half in the US. Junko obtained a degree in International Business with emphasis in Asian culture.