Matilde Sanchez-Kam
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Matilde Sanchez-Kam Email & Phone Number

Division Director, Analytics and Informatics, Office of Biostatistics, CDER, FDA at FDA
Location: New Alexandria, Virginia, United States 6 work roles 3 schools
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Current company
FDA
Role
Division Director, Analytics and Informatics, Office of Biostatistics, CDER, FDA
Location
New Alexandria, Virginia, United States
Company size
17700 employees

Who is Matilde Sanchez-Kam? Overview

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Matilde Sanchez-Kam is listed as Division Director, Analytics and Informatics, Office of Biostatistics, CDER, FDA at FDA, a with 17700 employees, based in New Alexandria, Virginia, United States. AeroLeads shows a matched LinkedIn profile for Matilde Sanchez-Kam.

Matilde Sanchez-Kam previously worked as Principal Statistical Consultant at Sanchezkam, Llc and Vice President, Head of Biostatistics and Data Management at Arena Pharmaceuticals. Matilde Sanchez-Kam holds Phd, Statistics from Penn State University.

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FDA

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Profile bio

About Matilde Sanchez-Kam

Collaborative biostatistics executive with significant experience in building a biostatistics and data management department in a small biopharmaceutical company and leading a therapeutic area statistics group in a large pharmaceutical company. Creative, analytical and detail-oriented; able to identify needs and develop solutions that meet statistical, regulatory and project requirements.• Instrumental in taking a small, biopharmaceutical company engaged primarily in research and development to successful approval of the first new treatment for obesity in more than a decade.• Therapeutic area experiences: endocrine and metabolic, pulmonary, sleep, pain, gastroenterology and cardiovascular.• Subject matter expert in regulatory meetings (FDA, EU, Japan, Canada, Mexico) including pre-IND, end of Phase 2, pre-NDA and Advisory Committee meetings.• Initiated statistical education outreach on statistical concepts and methodologies relevant to scientific research and clinical trials to preclinical and clinical colleagues.

Listed skills include Clinical Development, Clinical Trials, Biostatistics, Clinical Research, and 12 others.

Current workplace

Matilde Sanchez-Kam's current company

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FDA
Fda
Division Director, Analytics and Informatics, Office of Biostatistics, CDER, FDA
Belle Haven, VA, US
Website
fda.gov
Employees
17700
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6 roles · 31 years

Matilde Sanchez-Kam work experience

A career timeline built from the work history available for this profile.

Division Director, Analytics And Informatics, Office Of Biostatistics, Cder, Fda

Fda

Belle Haven, Va, Us

Role listed

Fda

Belle Haven, Va, Us

Division Director, Analytics And Informatics, Office Of Biostatistics, Cder, Fda

Fda

Silver Spring, Md, Us

Principal Statistical Consultant

Sanchezkam, Llc

Provides statistical expertise on development strategy, design, analysis and interpretation of Phase I-III clinical studies, including single ascending dose, multiple ascending dose, dose-ranging, pharmacokinetic, pharmacodynamic, drug interactions, safety and efficacy studies to small pharmaceutical companies. Client projects include: • Prepared statistical sections of study protocols, Clinical Study Reports (CSR) and Statistical Analysis Plans (SAP)• Acted as a subject matter expert for regulatory queries,meetings and Data Monitoring Committee (DMC)

2016 - 2017 ~1 yr

Vice President, Head Of Biostatistics And Data Management

Arena Pharmaceuticals

San Diego, Ca, Us

This department provides biostatistical, statistical programming and data management support to all phases of Arena’s drug development programs.

2007 - 2016 ~9 yrs
Team & coworkers

Colleagues at FDA

Other employees you can reach at fda.gov. View company contacts for 17700 employees →

EP Elizabeth Philpy Elizabeth Philpy Colleague at FdaGreater Minneapolis-St. Paul Area, United States View → FY Farid Yaghouby Farid Yaghouby Colleague at FdaWashington Dc-Baltimore Area, United States View → IC Iris Cheng Iris Cheng Colleague at FdaRockville, Maryland, United States View → AD Andre D. Andre D. Colleague at FdaBear, Delaware, United States View → MG Mustafa Guzel Mustafa Guzel Colleague at FdaIstanbul, Türkiye, Turkey View → NS Nicole Silva Nicole Silva Colleague at FdaBethesda, Maryland, United States View → LN Lindsey Nielsen Lindsey Nielsen Colleague at FdaGrand Island, Nebraska, United States View → RM Rebecca Minutillo Rebecca Minutillo Colleague at FdaWood Dale, Illinois, United States View → SS Skyler Smith Skyler Smith Colleague at FdaCincinnati, Ohio, United States View → DC Dakshina Chilukuri Dakshina Chilukuri Colleague at FdaHerndon, Virginia, United States View →
3 education records

Matilde Sanchez-Kam education

Phd, Statistics

Penn State University

Ma, Statistics And Operations Research

Penn State University

Bs, Statistics

University Of The Philippines
FAQ

Frequently asked questions about Matilde Sanchez-Kam

Quick answers generated from the profile data available on this page.

What company does Matilde Sanchez-Kam work for?

Matilde Sanchez-Kam works for FDA.

What is Matilde Sanchez-Kam's role at FDA?

Matilde Sanchez-Kam is listed as Division Director, Analytics and Informatics, Office of Biostatistics, CDER, FDA at FDA.

Where is Matilde Sanchez-Kam based?

Matilde Sanchez-Kam is based in New Alexandria, Virginia, United States while working with FDA.

What companies has Matilde Sanchez-Kam worked for?

Matilde Sanchez-Kam has worked for Fda, Sanchezkam, Llc, Arena Pharmaceuticals, and Merck Research Laboratories.

Who are Matilde Sanchez-Kam's colleagues at FDA?

Matilde Sanchez-Kam's colleagues at FDA include Elizabeth Philpy, Farid Yaghouby, Iris Cheng, Andre D., and Mustafa Guzel.

How can I contact Matilde Sanchez-Kam?

You can use AeroLeads to view verified contact signals for Matilde Sanchez-Kam at FDA, including work email, phone, and LinkedIn data when available.

What schools did Matilde Sanchez-Kam attend?

Matilde Sanchez-Kam holds Phd, Statistics from Penn State University.

What skills is Matilde Sanchez-Kam known for?

Matilde Sanchez-Kam is listed with skills including Clinical Development, Clinical Trials, Biostatistics, Clinical Research, Drug Development, Regulatory Submissions, Edc, and Clinical Data Management.

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