Cemal Unal, PhD
Cemal Unal, PhD, launched Biometrical Solutions in 2010 after holding executive leadership positions at global biopharmaceutical and clinical research organizations for over 15 years.
Dr. Unal's combination of scientific and operational expertise provides clear benefits to clients at each stage of the Phase I-IV clinical trial continuum, including:
- Trial design (adaptive, two-stage)
- Power/Sample Size Calculations
- CRF Design
- Protocol Writing
- Statistical Analysis Plan
- Interim Analyses (e.g. stopping rules, timing etc.)
- Data Safety Monitoring Board (DSMB)
- SAS Programming (e.g. Tables/Listings/Figures)
- Quality Assurance and Validations of TLFs
- NDA Submission Support
His statistical expertise has been applied to some of the most challenging therapeutic areas, including oncology, infectious disease, cardiovascular, endocrinology and metabolism.
Dr. Unal earned his PhD in Statistics from North Carolina State University, Raleigh NC.
I had the pleasure of working with Cemal for the past 4 years. Cemal leads his team at Prozen with professionalism, clarity, and enthusiasm. He is not only knowledgeable in the area of biostatistics but also in drug product development strategies. Cemal is very personable as it is evidenced by his professional and personal relationships with his colleagues, including myself. When ever I had questions for Cemal, he has always taken the time to thoroughly explain/address them. I believe his is a teacher at heart. Cemal significantly contributed to the approval of Prozen most recent drug product, Vimovo (combination tablet containing naproxen and esomeprazole). He was able to adequately address all of the FDA questions and concerns that were associated with the review and approval of the NDA. Cemal will be a great asset to any company.
Cemal was creative and industrious with all the activities in biometry, statistical planning for clinical studies, and applications in analyses and report writing. He took great care in providing the right analytical framework for the research that was being conducted. I would highly recommend him and his company.
Cemal and I have worked together for the past 5 years. Cemal was the head of biostatistics and one of the key active participants in all discussions of clinical trial design and data analysis. Cemal was always creative, eager to volunteer and willing to teach. Cemal comes loaded with personality and a positive outlook. I have no doubts Cemal will earn success in his new business venture and I have no reservations recommending him and his colleagues for your clinical trial design and biostatistics needs.
Cemal is an excellent statistician and manager. His pharmaceutic experience is extensive and valuable. He is a pleasure to work with and contributed many creative insights.
Cemal is a very experienced statistician and has great knowledge about the application of statistics in clinical trials. His experiences in both large pharmaceutical, biotechnology, and CRO makes him understand all aspects in design and analysis of clinical trials. He has lead a team of statisticians in his company to the successful approval of several NDAs.
Cemal is a great manager who understands the strength of each employee and gives them the opportunity to excel. He effectively motivates employees to go above and beyond, but respects the fact that all have a life outside of work. He is also a good mentor who has many years of experience in drug development.