About

Maher Issa

I’m Maher Issa, founder of issaStat Consulting, with over 30 years of experience as a biostatistician in the pharmaceutical industry. Since 1995, I’ve worked extensively on the design and analysis of clinical trials, supporting every stage of drug development—from protocol creation and statistical programming to report writing, regulatory submissions, and labeling.

Throughout my career, I have contributed to clinical research across various therapeutic areas, including pain management, cardiovascular disease, gastrointestinal disorders, respiratory conditions, immunology, oncology, COVID-19, diabetes, obesity, and vaccines.

I bring in-depth knowledge of global regulatory requirements, having successfully led multiple submissions and responded to regulatory authority requests that resulted in worldwide product approvals. My efforts have been recognized through research and development awards, certificates, and letters of commendation for successful regulatory submissions.

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I have:

• Led major safety-focused submissions that resulted in worldwide approval of four key immunology indications

• Guided efficacy and safety submissions for therapies in diabetes and vaccines

• Served as a subject matter expert for Data Monitoring Committees (DMCs), leading more than 8 DMCs

• Advised cross-functional teams to shape strategic decisions across therapeutic platforms

• Trained personnel in statistical principles, tools, and industry-standard procedures

• Authored over 30 scientific disclosures