About Us

Founder

Principal Biostatistician

Greg Maislin founded Biomedical Statistical Consulting in 1986 upon completing his graduate work at the Wharton School of the University of Pennsylvania. He has decades of experience applying statistical methods in medical device trials and in representing sponsors of medical device trials in FDA proceedings, including pre-submission and panel meetings.

As Adjunct Professor of Statistics in Medicine at the University of Pennsylvania Perelman School of Medicine, he serves as Director of the Biostatistics and Data Management Core for the Division of Sleep Medicine. He is an internationally recognized expert in biostatistical analysis in sleep research.

His statistical interests include methods for randomized clinical trials, propensity score methods to reduce bias in non-randomized studies, adaptive clinical trial designs including Bayesian statistical methods, longitudinal data analysis, and methods for missing data. He has authored or co-authored more than 200 scholarly articles in a wide range of medical research areas. His published work has been cited more than 25,000 times.

Greg holds a B.S. in Economics, an M.S. in Operations Research, an M.A. in Statistics, and completed coursework for a Ph.D. in statistics from The Wharton School of the University of Pennsylvania before founding BSC.

Greg has been married to Lu for more than 30 years. They have two sons, David and Brian. David works with his father at BSC.

President and CEO

David Maislin takes pride in providing BSC's clients with the highest quality biostatistical support services. David joined BSC in 2012 and now serves as Managing Partner. In his role as a Biostatistician, David works directly with clients and regulatory advisors throughout the lifecycle of FDA and Regulatory submissions. As Managing Partner, David leads the day-to-day company operations of the BSC Team. He plays a key role in identifying, maintaining, and managing strategic partnerships and is responsible for ensuring the efficient execution of Company initiatives.

David specializes in developing innovative clinical trial designs that accommodate unique situations and data sets, including novel algorithms and simulations for Bayesian adaptive designs, longitudinal data analysis, complex CT and MRI data, missing data, and survival data. He has expertise in Probabilistic programming languages and extensive experience with R, SAS, IML, and SQL programming, as well as high-performance cloud computing.

Since 2016, David has also worked as a biostatistician for the University of Pennsylvania Perelman School of Medicine’s Center for Sleep and Circadian Neurobiology. He performs and presents the results from statistical analyses of NIH-funded clinical trials and develops algorithms to synchronize high-frequency cardiovascular data to support personalized medicine and telemedicine ventures.

David has co-authored studies on orthopedic devices and sleep apnea in journals including Quantitative Imaging in Medicine and Surgery, Journal of Spine & Neurosurgery, and Sleep. David studied at the Pennsylvania State University.

Associate Principal Biostatistician

Brendan Keenan joined BSC in 2012. He designs clinical trials and statistical analysis plans; conducts simulated analyses of clinical trial characteristics; and performs advanced statistical programming techniques to report on the results of clinical trials. His primary focus is designing and implementing propensity score (PS) methods in clinical trials. He has played a key role in many FDA and other regulatory submissions, including as a blinded PS design statistician in multiple reviewed and approved spine and orthopedic PMA and 510k trials.

Brendan is also the co-director of the Biostatistics Core in the Division of Sleep Medicine at the University of Pennsylvania, where he oversees the day-to-day implementation of the strategy and activities of the Core. He collaborates with students and faculty in designing and implementing grant proposals and ongoing research projects within the Division. Previously, Brendan was the Biostatistician in the Center for Sleep and Circadian Neurobiology and Division of Sleep Medicine.

Brendan has a diverse background in academic research and varied statistical applications for several different diseases, including rheumatoid arthritis, systemic lupus erythematosus, Alzheimer’s disease, multiple sclerosis, and a variety of sleep and circadian disorders. He has co-authored at least 90 articles, including more than 100 related to sleep and sleep disorders.

Brendan earned a B.A. in Mathematics and Philosophy from Boston College and an M.S. in Biostatistics from the Harvard School of Public Health. He grew up in Boston and lives in New Jersey with his wife and sons.

Director of Operations

Dani Clovie is a results-driven Program/Project Manager with experience in the MedTech and Medicare compliance industries. Throughout her career, she has demonstrated versatility, operating on both sides of the aisle in commercial operations and regulatory affairs/quality assurance. Dani has contributed her expertise to documentation, training, reporting and analytics, customer support, and program/project management. Her passion lies in undertaking large-scale, cross-functional projects, where she excels in building scalable structures, ensuring compliance, and refining processes within organizations.

Prior to joining BSC, Dani was responsible for establishing a robust project management structure across a global organization. She adeptly managed operations for another global organization including all aspects of project administration for regulatory, quality, and clinical strategic Imperatives.

Dani holds a Bachelor of Arts degree from Southern New Hampshire University. She has furthered her education with certifications in Project Management and Leadership from Cornell University and is on track to achieve her PMP certification. As a Smartsheet Certified Project Manager and Core Product Certified Professional, Dani brings a wealth of skills to any project.

Dani currently reside just north of Boston and enjoys spending time with her husband, young son, and two cats.

Biostatistician

Austin Collins’ experience in clinical trial design, analysis, and programming spans multiple industries. Specifically, Austin has supported global companies developing innovative implantable cardiac devices, stents, spinal neuromodulation devices, in-vitro diagnostics, AI-powered heart diagnostics, and oncology treatments. Austin synthesized data from Medicare claims, clinical trials, simulations, and patient device transmissions throughout these projects to support regulatory submissions, real-world evidence initiatives, and academic publications. Austin’s background includes programming using SAS, R, and Python to develop automated analysis systems, data warehouses, and complex statistical reports.

Austin has always been interested in the intersection between healthcare and mathematics. He earned a Bachelor of Science in Biochemistry with a minor in Math from Indiana University. In his undergraduate studies, he completed a research thesis on the X-ray crystallography structures of enzyme-bound novel antifolate compounds. He later earned a Master of Science in Biostatistics from Oregon Health and Science University. Austin completed a research assistantship at the Knight Cancer Center during his graduate program, focused on methodology simulation studies of novel Bayesian designs for phase I oncology clinical trials. 

 While Austin grew up in northern Indiana, he now calls Oregon home.

Senior Biostatistician

Melissa Gottschalk is a senior biostatistician with a career spanning public and military sectors with extensive biostatistics, clinical trials, and public health expertise. She enjoys collaborating with fellow statisticians and clinicians, utilizing SAS to analyze data and complex clinical trials.

Melissa gained valuable business analyst and biostatistician experience while working for some of the world’s largest global healthcare organizations. During this time, she utilized publicly available data to create a machine learning scoring algorithm assessing social determinants of health. Her contributions extended to evaluating new market developments and supporting M&A teams. Melissa is an expert in clinical trial analysis, protocol and clinical study report writing, longitudinal analysis, survey writing and analysis, and predictive modeling. 

Melissa began her educational journey by earning a Bachelor’s in Science from California State University Long Beach, majoring in biology with an option in physiology and a minor in chemistry. She later attended Loma Linda University where she earned a dual degree in biostatistics and epidemiology in the form of a Master’s in public health. She has presented at multiple military and academic conferences as well as at SAS Global Forum, and she has authored numerous publications in academic, military, and professional journals.

In Melissa’s personal time, she volunteers by teaching yoga classes to raise money for local charities in the San Diego area. She also enjoys traveling and spending time with her husband, son, French bulldog, chickens, and horses.

Senior Statistical Programmer

Bob Hachadoorian joined BSC in 1990 and is the team’s most senior SAS programmer and data analyst. He specializes in data processing, management, and statistical analysis of clinical trials, and advises clients throughout the FDA submission process.

In his more than 30 years at BSC, Bob has worked with clients, regulatory advisors, and clinical research organizations on hundreds of successful submissions to the FDA and academic journals. He has also worked oncollaborative projects with Industry Sponsors, including Vertiflex Superion, Orthofix M6-C, and MCRA.

In conjunction with his role at BSC, Bob served for 20 years as a statistical programmer and analyst at the University of Pennsylvania’s Center for Sleep and Respiratory Neurobiology, where his responsibilities included data management and statistical programming within SAS, SPSD, and BMPD statistical applications.

Bob has co-authored articles on orthopedics, sleep deprivation, and sleep apnea in medical journals including Sleep and the American Journal of Respiratory and Critical Care Medicine.

Bob earned a B.A. in Philosophy from Marquette University, and completed graduate work in philosophy at Villanova University. He lives in Pottstown, PA.

Biostatistician

Lucia Hernandez, who joined BSC in 2022, is a statistician with over ten years of experience working as a consultant. Her expertise areas are modeling, data analysis, and the design of experiments. She has extensive experience with statistical analysis software, including SAS, R, SPSS, and Minitab. Between 2010 and 2021, Lucia was a professor at the Faculty of Economic Sciences and Statistics of the National University of Rosario in Argentina, teaching master's and doctoral level courses in applied statistics as Design of Experiments and Sampling Methods in Censuses and Surveys.

She earned a B.S in Statistics and a Ph.D. in Statistics from the National University of Rosario (Argentina). Her doctoral thesis addressed topics of design of experiments and was developed during her stay as a visiting Ph.D. student at the University of Minnesota, USA.

Biostatistician

Josh Rapkin has experience acting as a biostatistician and leading teams of statisticians and statistical programmers in supporting regulatory reporting for numerous U.S. Food and Drug Administration (FDA) submissions. Josh participated in premarket approval (PMA) submissions, FDA panel meetings, in-person and virtual FDA meetings, deficiency responses, and regulatory report submissions. He has also worked on many statistical analysis plans and sections of protocols and has experience programming in SAS and R. Known for communicating ideas clearly and effectively, Josh collaborates well with statisticians and non-statisticians alike.

Josh earned undergraduate degrees in Applied Mathematics and Biochemistry from the University of Washington. After spending a year conducting research at the National Cancer Institute in Bethesda, Maryland, he spent the next two years obtaining his Master's in Biostatistics from the University of Minnesota. He has worked for two of the world’s largest medical device companies, building experience in many therapeutic areas, such as structural heart, cardiac rhythm management, electrophysiology, neuromodulation, spine, and more. 

Josh is married and has four children. Josh enjoys time with his family, cooking, and playing the guitar during his spare time.

Senior Biostatistician

Laura earned a B.S. in Mechanical Engineering and Management from MIT and an M.Sc. in Health Policy and Management from the Harvard School of Public Health. Prior to joining BSC in 1999, she worked in academic, corporate, and government consulting. As a trained health economist and expert in decision analytic modeling [see PMID: 14595039, > 100 citations] who has worked with leading research teams at the Harvard School of Public Health, Dana-Farber Cancer Research Center, and Children’s Hospital of Philadelphia.

She now specializes in applying SAS & R software to conduct statistical analyses for clinical trials, R&D, and marketing support. She regularly contributes to manuscripts and regulatory submissions to the FDA for new medical treatments and devices, including INDs/NDAs, PMAs, and IDEs submissions, and also serves as a biostatistical consultant to departments at the University of Pennsylvania’s Perelman School of Medicine as well as other academic clients.