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Debra Bernstein Email & Phone Number

Biostatistician, PhD with expertise in the pharmaceutical industry at Pharmaceutical Companies
Location: New York City Metropolitan Area, United States, United States 6 work roles 1 school
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Role
Biostatistician, PhD with expertise in the pharmaceutical industry
Location
New York City Metropolitan Area, United States, United States
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Who is Debra Bernstein? Overview

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Debra Bernstein is listed as Biostatistician, PhD with expertise in the pharmaceutical industry at Pharmaceutical Companies, a company with 459 employees, based in New York City Metropolitan Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Debra Bernstein.

Debra Bernstein previously worked as Senior Director Biostatistics at Pharmaceutical Companies and Senior Director, Biostatistics at The Medicines Company. Debra Bernstein holds Doctor Of Philosophy (Ph.D.), Statistical Science from University At Buffalo.

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Pharmaceutical Companies

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Profile bio

About Debra Bernstein

Doctorate in statistics with extensive experience in the pharmaceutical industry. Expertise in matched pairs, categorical, binomial and crossover data analysis, ANOVA, nonparametric methods, and graphics. Knowledgeable in all developmental stages from pre-clinical to Phase I-IV & Consumer Health Care. This includes the design of studies and case report forms, SAPs, data analysis, report writing, publications and collaborating closely with medical personnel. Oversaw all statistical aspects of numerous approved FDA/EMEA regulatory submissions. Wide-ranging computer programming experience with SAS using various database systems.

Listed skills include Pharmaceutical Industry, Clinical Trials, Biostatistics, Clinical Development, and 18 others.

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Pharmaceutical Companies
Pharmaceutical Companies
Biostatistician, PhD with expertise in the pharmaceutical industry
New York, NY, US
Website
Employees
459
AeroLeads page
6 roles · 38 years

Debra Bernstein work experience

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Senior Director Biostatistics

Current
Pharmaceutical Companies
2016 - Present ~10 yrs 4 mos

Senior Director, Biostatistics

East Hanover, NJ, US

Biostatistics Senior Director in charge of all statistical/programming work for a cardiovascular compound at The Medicines Company. Completed a pediatric extension approved by the FDA and several Type II variations granted from the EMEA. Work on this drug involves writing SAPs and ISAPs and producing TFLs for its Phase IV and DUS studies in addition to.

2013 - 2016 ~3 yrs

Biostatistical Consultant

East Hanover, NJ, US

Worked on a sNDA & manuscripts in the cardiovascular area on a contract basis.

2007 - 2007

Biostatistical Consultant

Pharmaceutical Companies
  • Work done for Allergan, Enzon Pharmaceuticals, Schering-Plough Corporation, TKL Research, SmithKline Beecham, Parke-Davis, Berlex Laboratories and other pharmaceutical companies on a consulting basis.
  • Consulting statistician at Allergan working on Botox reformulation from 2005 to 2007. Wrote statistical analysis plans including shell tables and verified programming for table generation.
  • Sole statistical representative on team submitting a supplemental BLA for an acute lymphoblastic leukemia treatment at Enzon from 2004 to 2005.
  • Statistical Consultant in the Schering-Plough Corporation Medical and Scientific Affairs Phase IV department from 1997 to 2004. Covered several therapeutic areas with an emphasis in allergy/asthma. Supervised the.
  • Statistician at TKL Research, a contract research organization that conducted clinical trials on both Rx and OTC products including mouthwash, nicotine patches and pain remedies for 1 year. Responsible for generation.
  • Acting Director Worldwide Biostatistics at SmithKline Beecham Consumer Healthcare for 1 year. Supervised department, completed large PMS NDA submission.
1988 - 2007 ~19 yrs
Team & coworkers

Colleagues at Pharmaceutical Companies

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1 education record

Debra Bernstein education

  • University At Buffalo
    University At Buffalo
    Statistical Science
FAQ

Frequently asked questions about Debra Bernstein

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What company does Debra Bernstein work for?

Debra Bernstein works for Pharmaceutical Companies.

What is Debra Bernstein's role at Pharmaceutical Companies?

Debra Bernstein is listed as Biostatistician, PhD with expertise in the pharmaceutical industry at Pharmaceutical Companies.

Where is Debra Bernstein based?

Debra Bernstein is based in New York City Metropolitan Area, United States, United States while working with Pharmaceutical Companies.

What companies has Debra Bernstein worked for?

Debra Bernstein has worked for Pharmaceutical Companies and The Medicines Company.

Who are Debra Bernstein's colleagues at Pharmaceutical Companies?

Debra Bernstein's colleagues at Pharmaceutical Companies include Narendra K, Mira Gayed, Muhammad Laraib, Aya Abdelrahman, and Yasmin Shaikh.

How can I contact Debra Bernstein?

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What schools did Debra Bernstein attend?

Debra Bernstein holds Doctor Of Philosophy (Ph.D.), Statistical Science from University At Buffalo.

What skills is Debra Bernstein known for?

Debra Bernstein is listed with skills including Pharmaceutical Industry, Clinical Trials, Biostatistics, Clinical Development, Regulatory Submissions, Oncology, Fda, and Life Sciences.

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