プロフィール詳細

プロジェクトを作成

★★★★★

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★★★★★

☆☆☆☆☆

Barbara E.に依頼

United States

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

プロフィール概要

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.

専門分野

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

サービス

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation

Research Scientific and Technical Research, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

職務経験

Adjunct Lecturer

University of California Berkeley Extension

1月 2020 - 現在

Biostatistics consultant

Consulting

1月 2000 - 現在

Statistical Reviewer

FDA

6月 1995 - 1月 2001

学歴

Masters in Public Health- Biostatistics

Harvard University

9月 1993 - 6月 1995

MS (Biostatistics)

Harvard School of Public Health

- 1995

認定資格

• 認定資格の詳細は未入力です。

出版物

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). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 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). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 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). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 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). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 1890-1900.