About Sterling bioAnalytics

Our Vision

Our vision is to become a world class statistical service provider, render state of the art statistical support affordable to all and ensure the best out-sourcing experience from beginning to end.

Alex D. Kouassi Ph.D., M.S.

Founder & CEO

Dr. Alex D. Kouassi is an accomplished Biostatistics Leader with over two decades of experience in the pharmaceutical industry, Biotech and CROs. Dr. Kouassi has led clinical Biostatistics teams across a wide range of therapeutic areas including but not limited to:

• CNS: Sleep disorders, major depressive disorders, mood & psychotic disorders,
  traumatic brain injuries and dementia.
• Oncology: Solid and liquid tumors
• GI: Opioids induced constipation, Crohn’s disease and Ulcerative colitis
• Rare diseases: Limb girdle muscular dystrophy
• Vaccine: Covid-19 protein vaccine

Known for his strategic thinking and collaborative leadership style, he has successfully
led statistical teams through all phases of clinical trials, supporting numerous regulatory
submissions.
Throughout his career, Dr. Kouassi has held senior leadership positions at industry-
leading organizations such as Merck Laboratories and Novartis Corporation. He has
played a pivotal role in the development and regulatory approval of critical therapies.
His contributions have consistently ensured scientific rigor, regulatory compliance, and
impactful health outcomes.
In addition to his industry work, Dr. Kouassi has contributed to academic research
through peer-reviewed publications and has taught university-level statistics and
mathematics courses. He holds a Ph.D. in Statistics from Temple University and an
M.S. in Statistics from Rutgers University. Passionate about mentoring and innovation,
Dr. Kouassi continues to shape the future of biostatistics through both practice and
thought leadership.
Sterling Bioanalytics was founded to offer clinical researchers:

• Personalized statistical support, from innovative trial designs to in-depth data
  analyses, tailored to meet their unique needs.
• High level assistance in interpreting analysis results for clinical reports.
• Excellent support for regulatory submissions, from the preparation of ISS and
  ISE SAPs to thorough data analyses.

To students working on a Ph.D. dissertation, master’s thesis, journal article, conference
presentation or research proposal, Sterling Analytics is here to assist you at every stage
of your research journey.

Key Team Expertise

CAREER SUMMARY

• Pharmaceutical Biostatistics professional with over 30 years of experience in:
  • • NDA, MAA, TGA and PMDA submissions
    • NDA, MAA, and PMDA inspections
• Biostatistical Analyses of Clinical and pre-clinical Trials
• Extensive experience in PK / PD analyses
• Programming expertise in a broad variety of statistical software packages including SAS, PASS, R, NCSS, nQuery, WinNonLin, EAST, JMP, etc.
• Experience with CDX.
• Excellent SAS programmer.

THERAPEUTICS EXPERTISE

• Oncology
• Ophthalmology
• Hematology
• Pain
• Virology
• Neuroscience

 

Design and analyses of the following clinical pharmacology studies for Oncology, Immunology, Lupus and Atopic dermatitis indications: 

• Non-compartmental Pharmacokinetics
• Dose Proportionality (DP)
• Renal and Hepatic Impairments
• Age and Gender effect, Food and PH effects
• Drug-Drug interaction (DDI).
• Relative and absolute Bioavailability (rBA, BA)
• Bioequivalence (BE)