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Being a Medical Statistician in the Pharmaceutical

Industry

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Topics• What is the Pharmaceutical/Pharma Industry?

• How do we develop drugs?• An example of how statisticians get involved• Opportunities, qualifications, my experience• Summary

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What is the Pharmaceutical Industry?

• Develops medicines

• Successful and growing industry

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A few examples…

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Drug Development Process - Overview

• Aim: to gather enough evidence to prove that a drug is safe and effective for a particular disease.

• Developing a new medicinecosts over $500 million andtakes over 12 years.

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Drug Development Process

Drug Discovery

Pre-clinical

Clinical trials(people)

AuthorisationSales & Marketing

Manufacturing

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Why is medical statistics is important – are doctors enough?

"Smoking cigarettes causes lung cancer“

Since the first research showed that smoking was bad for you 60 years ago we have:

Flu jab, pace makers, kidney transplants, inhalers, polio/measles/mumps/ meningitis/rubella/ small pox vaccines

Test tube babies, cloning

Many many others…

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Example of problem a statistician has to solve – Trial Design

You have 2 drugs (Drug A and Drug B) and a placebo

Which drug is better A or B?

A B

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Trial design options (9 patients)

Option 1

No patients

Visit 1 Visit 2 Visit 3

9 Drug A Placebo Drug B

No Patients Visit 1

3 Drug A

3 Drug B

3 Placebo

Option 2

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Trial design options (9 patients)

No Patients

Visit 1 Visit 2 Visit 3

3 Drug A Drug B Placebo

3 Placebo Drug A Drug B

3 Drug B Placebo Drug A

Option 3

Perfect!

(multiple solutions of course)

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Key Skills for a Statistician

• Good communication and presentation skills

• Can work well in a team and independently

• An eye for detail• Well organised• Logical thinker

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How did I get here?

• A Levels – Maths and Stats, English and Music. • BSc Maths and Stats - Southampton• MSc Statistics with Applications in Medicine –

Southampton (only 6-7 course in UK)

• Been working for 3-4 years• Worked across many areas including cancer,

depression, optometry, MRI, schizophrenia

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Why is it a great job?

• You are the expert, the specialist, the teacher.• You work with top doctors, scientists, experts

in fields, sales, academia

• Always part of a team• Never stop learning• Massive variety

• Generous benefits and competitive salaries• Opportunities for travel• You make a real difference

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To Summarise...

• Applying your education to help improve health and save lives

• Growth industry

• Good career prospects

• Make a difference

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BACK UP SLIDES

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Discovery/Pre-clinical

• Creating molecule• Testing in test tubes (on blood

etc)• Animal testing

• Is it safe?• Is it ready for humans?

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In the Clinic - Phase I

• Small sample of healthy volunteers • Volunteers are closely monitored

• How much should you take?• How often should you take it?• Do you take it with food?• Can you take it with other drugs?

• Safety Safety Safety

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In the Clinic - Phase II and III

• First time drug is given to patients • Aim to show the drug works - Does

it do what it says on the tin?

• Usually larger than Phase I studies• Usually longer duration than Phase I

studies

• Licence application • Safety

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In the Clinic - Phase IV

• After the drug has been licensed for prescription by doctors

• To provide supporting data for further investigations

• Marketing