Epidemiologist · Biostatistician · Expert Consultant

Marcelle M.
Dougan

ScD, MPH, MEng  ·  Harvard · Imperial College · MIT

I bring the rigor of Harvard-trained epidemiology, eight years inside Merck's pharmaceutical operations, and the analytical depth of a practicing biostatistician to every engagement — whether that's designing a clinical study, advising on real-world evidence, or providing expert opinion in litigation.

Discuss an engagement →
Doctorate Harvard University
ScD Epidemiology
Engineering Imperial College
MEng Chemical Eng.
AI & Machine Learning MIT Certificate
2025
Industry Merck & Co.
8 Years · API Production
Faculty San José State
Tenured Professor
Active Grant NIA · $3.4M
Methodological Expert

The full pipeline — from manufacturing floor to regulatory submission

Most epidemiologists have never set foot inside a pharmaceutical plant. Most engineers have never designed a prospective cohort study. I have done both — and that combination is what makes my consulting practice genuinely different.

I spent eight years at Merck & Co. as a process engineer managing the production of bulk Active Pharmaceutical Ingredients at commercial scale, within GMP and regulatory compliance environments. I then earned my Doctor of Science in Epidemiology from Harvard, completed postdoctoral training at Brigham and Women's Hospital and Stanford Cancer Institute, and earned an AI and Machine Learning certificate from MIT in 2025.

I am currently a tenured Professor at San José State University and serve as named methodological expert on a $3.4 million NIA-funded study. I have authored more than 20 peer-reviewed publications in journals including the American Journal of Obstetrics & Gynecology, International Journal of Cancer, and American Journal of Epidemiology.

I work with pharma companies, biotechs, CROs, health systems, and legal teams that need senior-level scientific expertise — with the credibility to back every opinion up in writing or on a witness stand.

  • Harvard ScD, Epidemiology · Minors: Biostatistics, Maternal & Child Health
  • Imperial MEng, Chemical Engineering (with honors) · London, UK
  • MIT Certificate, AI & Machine Learning · 2025
  • Columbia MPH, Epidemiology
  • Stanford Postdoctoral Research Scholar · Cancer Institute
  • Harvard Postdoctoral Trainee · Brigham and Women's Hospital
  • Merck Process Engineer · API Production · GMP · 8 years
  • NIA Methodological Expert · $3,432,146 active grant (2023–2027)

Areas of Expertise

Where I can provide authoritative opinion

Epidemiology & Causation

Causal inference, exposure-outcome relationships, risk factor analysis, and evaluation of confounding, bias, and methodological adequacy in published studies.

Expert testimony · Mass tort · Personal injury
📊

Biostatistics & Study Design

Statistical analysis plan design and critique, sample size and power, survival analysis, regression modeling, and longitudinal data analysis.

SAP review · Clinical trial methodology
🏭

Pharmaceutical Manufacturing

API production processes, GMP compliance, pharmaceutical quality systems, and operational decision-making inside major pharma companies — from direct industry experience at Merck.

Pharma liability · Product defect · Manufacturing negligence
🔬

Oncology & Women's Health

Breast, endometrial, liver, lung, and prostate cancer epidemiology. Reproductive health, endometriosis, and in utero exposure outcomes from large prospective cohort studies.

Cancer causation · Pharmaceutical liability
🌿

Environmental Exposures & PFAS

Peer-reviewed published research on PFOA/PFOS serum levels and pregnancy outcomes (Am J Epidemiology, 2009). Direct expertise in environmental contaminant exposure and birth outcome litigation.

Toxic tort · PFAS litigation · Environmental health
🤖

AI & Machine Learning in Health

Applications of machine learning and AI to epidemiologic surveillance, clinical prediction, and public health analytics — with MIT certificate and active research program.

Digital health · AI methodology · Emerging evidence

Track Record

Credentials that hold up under scrutiny

20+ Peer-reviewed
publications
$4M+ Federal grant
portfolio
25+ Years combined
experience
35+ Media appearances
as expert
8 Years at Merck
pharmaceuticals
Cited as expert by
ABC7 / KGO-TV KQED KTVU-TV KRON-TV KCBS Radio Newsweek San Jose Mercury News Congressional CAPAC Brief San Jose Spotlight

Services

How I work with clients

Pharma & Biotech Consulting

Senior-level epidemiologic and statistical expertise for companies that need rigorous science without the full-time overhead.

  • Study design & statistical analysis plans
  • Real-world evidence & HEOR studies
  • Protocol review & methodology critique
  • Fractional Chief Biostatistician (retainer)
  • AI/ML in clinical research advisory

Expert Witness & Litigation Support

Available for case review, expert reports, deposition, and trial testimony in cases involving epidemiology, biostatistics, and pharmaceutical manufacturing.

  • Causation & risk analysis opinions
  • Statistical methodology critique
  • Pharmaceutical manufacturing & GMP
  • PFAS/PFOA environmental exposure
  • Oncology & reproductive health

Health Systems & Government

Research design, data analysis, and evidence translation for health systems, public health agencies, and foundations.

  • Health equity & SDOH analysis
  • Grant methodology & statistical design
  • COVID-19 & infectious disease epi
  • Policy brief & report development
  • Public health surveillance systems

Advisory & Speaking

Scientific advisory board membership and paid speaking on epidemiology, women's health, AI in public health, and health equity.

  • Scientific advisory board roles
  • Conference keynotes & invited lectures
  • Media commentary & expert interviews
  • Executive briefings on evidence
  • Curriculum & training development

Fees are commensurate with the nature and complexity of the engagement. A fee schedule is available upon request. Retainer agreements are required prior to commencing work.

Contact

Let's discuss your engagement

Available for consulting engagements, expert witness assignments, advisory roles, and speaking. Response within 24 hours.

Currently accepting new engagements