Dr. Cemal Unal has over 23 year experience in biostatistics and SAS programming in drug development worldwide.
He has provided long-term statistical expertise and SAS programming services to mid/small size pharma companies and CROs and serve as the principal statistician for client projects, leading project teams by example. Cemal has written protocols, statistical analysis plans, DSMB charters, performed SAS programming, conducted interim analysis, represented clients at FDA.
In his pharmaceutical projects, he has provided leadership to statisticians and statistical programmers locally and globally for oncology, diabetes, pain, and ulcers drug development programs while working in a multidisciplinary environment. Cemal has written protocols (including adaptive designs), conducted due diligence, calculated sample size and power, and wrote Statistical Analysis Plans. He has performed intense SAS programming for TLF production and QC. Represented companies at FDA and EMEA for end of phase II and pre-NDA meetings.
Cemal has also Worked in CRO’s with statisticians and statistical programmers on multiple projects for sponsors in a variety of therapeutic areas. Significant expertise in writing and developing SOPs, statistical analysis plans, CRF development as well as providing statistical consulting to sponsors for protocol development. Contributed to the development of a costing tool for biostatistics department. Proven ability to effectively interview, hire and train staff. Additionally, he has worked with business development for bids and contracts and given presentations at bid defense meetings. He has also helped in developing a bidding tool for biostatistics.