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Hire Barbara E.

United States

USD 250 /hr

Freelance Biostatistician with 25+ years of experience | Former FDA reviewer

Profile Summary

I help pharmaceutical & biotech companies achieve FDA regulatory success by leveraging my statistical expertise & deep industry knowledge across Pharma, IVDs and Medical Devices. I have a Masters in Biostatistics from Harvard University. I especially enjoy designing studies, and writing and reviewing complex SAPs.

Subject Matter Expertise

• ☆ Biostatistics
• ☆ Data Analysis
• ☆ Predictive Modeling & Analytics

Services

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation

Research Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Work Experience

Adjunct Lecturer

University of California Berkeley Extension

January 2020 - Present

Biostatistics consultant

Consulting

January 2000 - Present

Statistical Reviewer

FDA

June 1995 - January 2001

Education

Masters in Public Health- Biostatistics

Harvard University

September 1993 - June 1995

MS (Biostatistics)

Harvard School of Public Health

- 1995

Certifications

• Certification details not provided.

Publications

JOURNAL ARTICLE

Crespo-Leiro, M.G., Stypmann, J., Schulz, U., Zuckermann, A., Mohacsi, P., Bara, C., Ross, H., Parameshwar, J., Zakliczyński, M., Fiocchi, R., et al.(2016). Clinical usefulness of gene-expression profile to rule out acute rejection after heart transplantation: CARGO II . European Heart Journal. 37. (33). p. 2591-2601.

Grosu, D.S., Hague, L., Chelliserry, M., Kruglyak, K.M., Lenta, R., Klotzle, B., San, J., Goldstein, W.M., Moturi, S., Devers, P., et al.(2014). Clinical investigational studies for validation of a next-generation sequencing in vitro diagnostic device for cystic fibrosis testing . Expert Review of Molecular Diagnostics. 14. (5). p. 605-622.

Deng, M.C., Elashoff, B., Pham, M.X., Teuteberg, J.J., Kfoury, A.G., Starling, R.C., Cappola, T.P., Kao, A., Anderson, A.S., Cotts, W.G., et al.(2014). Utility of gene expression profiling score variability to predict clinical events in heart transplant recipients . Transplantation. 97. (6). p. 708-714.

Pham, M.X., Teuteberg, J.J., Kfoury, A.G., Starling, R.C., Deng, M.C., Cappola, T.P., Kao, A., Anderson, A.S., Cotts, W.G., Ewald, G.A., et al.(2010). Gene-expression profiling for rejection surveillance after cardiac transplantation . New England Journal of Medicine. 362. (20). p. 1890-1900.