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Internship at Inclin. Kelly Speth November 4, 2013. My Background & Experience. B.S. in Biological Sciences, Cal Poly State University Worked for 12+ years as a Clinical Research Associate and Clinical Project Manager for Pharmaceutical Drug Trials

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internship at inclin

Internship at Inclin

Kelly Speth

November 4, 2013

my background experience
My Background & Experience
  • B.S. in Biological Sciences, Cal Poly State University
    • Worked for 12+ years as a Clinical Research Associate and Clinical Project Manager for Pharmaceutical Drug Trials
  • Entered the M.S. Statistics program at San Jose State (2013)
my internship objectives
My Internship Objectives

Primary Objective:

  • To acquire statistical skills to make myself marketable after my internship (to pay my way through school)

Secondary Objectives:

  • Get exposure to different types of studies
  • Network with Biometrics professionals
  • Improve my SAS programming skills
inclin
Inclin

www.inclin.com

why i chose inclin
Why I Chose Inclin

Nearby!

of projects

big picture drug development
BIG Picture: Drug Development

Infinite !!!

6-10 Years

Primarily

Non-Human Studies

20-100 Healthy Humans

100-500 Diseased Humans

1000-5000 Diseased Humans

Kelly Philpot, PPD (2006)

clinical trials administration
Clinical Trials Administration

Within Biometrics:

-Biostatistics

-Clinical Programming

-Clinical Data Mgmt

Biometrics

Design * Data Collection * Analysis * Interpretation

projects
Projects
  • Perform SAS programming for secondary analyses for publications related to pregnancy-related risk factors (2 academic groups)
  • Create Statistical Analysis Plan and analysis listing shells for Phase I cancer study
  • Perform Quality Control (QC) for draft and final analysis tables and listings before they are submitted to client (multiple studies and clients)
  • Do research on topics relevant to a practicing biostatistician in drug development
sample project
Sample Project

Hello

I need a concordance analysis (see tables 2a and 3a on the attached) for the studies 112 and 113 combined. The attached is only for study 112.

There is an integrated database in the SponsorX folder in the following

C:\DATA\SASFiles\SponsorX\Integrated\Programming\Data

You can use ADEF and you will need to use PARAMN = 1 for early clinical response and then Paramn=3 for investigator response at EOT and 4 for IA response at PTE.

Sorry – But I have to run – so let me know any questions. That should give you a start

Thanks

sample project1
Sample Project

Specification

SAS Dataset Efficacy Data

Study 112

SAS Dataset Efficacy Data

Study 113

Table: Concordance Analysis for

Study 112

SAS Program

Deliverable

Table: Concordance Analysis for

Studies 112 and 113

SAS Output

what i got out of this internship
What I Got Out of this Internship

Primary Objective:

  • To acquire statistical skills to make myself marketable after my internship (to pay my way through school)

Secondary Objectives:

  • Get exposure to different types of studies
  • Network with Biometrics professionals
  • Improve my SAS programming skills
recommendations for those interested in clinical research
Recommendations for those Interested in Clinical Research
  • Job outlook is good!

“It’s very hard to find statisticians in the Bay Area because there are a lot of biotech companies but very few feeder schools.”

sf bay area biotechs
SF Bay Area Biotechs

http://iccweb.ucdavis.edu/hbs/pdf/Biotech%20Companies%202011.pdf

recommendations for those interested in clinical research continued
Recommendations for those Interested in Clinical Research (continued)
  • Take a course to understand the basics of clinical research and drug development
    • UC Berkeley Extension
    • UCSC Extension
  • Look at job descriptions for skills & education needed
      • Improve your SAS skills
      • Talk to me
recommendations for finding an internship
Recommendations for Finding an Internship
  • Determine what your interests are

Do an internship in a field that you are interested in working in

      • Understand (and acknowledge!) your unique skill set
  • Don’t give up – you are offering free labor!