Transcript Careers for Statisticians within the Pharmaceutical Industry

Careers for Statisticians and
Statistical Programmers
within the Pharmaceutical
Industry
Insert your name here
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What is the
Pharmaceutical Industry?
• Develops medicines
• Successful and growing industry
• Pharmaceutical, Biotechnology
and Medical Device companies
• Contract Research Organisations
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Drug Development Process Overview
• Aim: to gather enough evidence to
convince government agencies,
doctors and patients that a drug is
safe and effective as a treatment for
a particular disease.
• If an agency is convinced that a
drug works they will grant a license
to market the drug in their country.
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Drug Development Process
Drug
Discovery
Pre-clinical
Formulation
development
Clinical trials
Manufacturing
Sales &
Marketing
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Marketing
Authorisation
Discovery/Pre-clinical
• Target identification
• Creation and screening of new and old
drugs
• Testing of drugs:
–
–
–
–
Does it attach to the target?
Does it work once attached?
Is it specific?
Will it get into the body and stay for the
right amount of time?
– Is it safe?
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Phase I
• Check that the pre-clinical findings
are still true in man
• Small sample of healthy volunteers
• Volunteers are closely monitored
• Pharmacodynamics
and Pharmacokinetics
• Safety
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Phase II
• First time given to patients
• Aim to show efficacy
• Look at range of doses to find
therapeutic window
• Usually larger than Phase I studies
• Usually longer duration than Phase I
studies
• Usually only 2 or 3 studies
• Safety
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Phase III
• Aim to provide enough evidence to show
regulatory authorities that the drug works
and is safe.
• Larger multi-centre studies
• Longer duration than Phase II
• At least 2 confirmatory studies (1 US, 1
ROW)
• Long Term Safety
• Pharmacokinetics e.g. drug interaction,
food effect etc.
• Licence application
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Phase IV
• After the drug has been licensed
for prescription by doctors
• To provide supporting data for
further investigations
• Marketing
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Licensing and Regulatory
• Food and Drug Administration (FDA)
– US
• European Medicines Evaluation
Agency (EMEA) - EU
• Ministry of Health and Welfare
(MHW) – Japan
• Medicines and Healthcare products
Regulatory Authority (MHRA) - UK
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Pharmacy and Production
• During Clinical Trials
– Formulation Development
– Assessing impurities and safety
– Scaling up drug creation
• Manufacturing
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Where are Statisticians
Involved?
• Nonclinical Statistics
– Drug Discovery
– Safety/Toxicology
– Pharmacy & Production
– Manufacturing
• Clinical Statistics
– Phases I-IV
– Licensing & Regulatory
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How is a Non-Clinical Statistician
involved?
• Supporting Drug Discovery or Pharmaceutical
Scientists
• Understanding new technologies in Drug
Discovery
• Quality control
• Designing & randomising studies
• Analysis and reporting of data
• Training Scientists
• Development of new software
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Clinical Trials Process – How is a
Clinical Statistician involved?
Study Design and Protocol Development
Randomisation and Blinding
Case Report Form Development
Data Validation Process
Writes Statistical Analysis Plan
Review of Blinded Tables and Listings
Database Lock
Interpretation and Presentation of results
Input into Clinical Report
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Clinical Trials Process – How is a
Statistical Programmer involved?
Case Report Form Development
Review Statistical Analysis Plan
Table production based on blinded data
Data Validation and QC
Database Lock
Production of Final Tables and Listings
Provide Support to Medical Writers
Pooling Studies for Regulatory Submissions
Support to Regulatory Documents and Queries
Software Development
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Interactions with People
CRAs
Medical Writers
Regulatory
Epidemiologists
Ethics
committees
Pharmacovigilence
Pharmacokinetics
Medical
Medics
Academia
Sales
Regulatory
Project
management
Data
management
Internal
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External
Opportunities
Management
• People
• Projects
Technical Expert
• Consultant
• Academia
SAS Programmer/Statistician
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Working Environment
• Good career progression
• Generous benefits and
competitive salaries
• Excellent working conditions
• Professional environment
• Continuing professional
development
• Opportunities for travel
• PSI involvement
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Qualifications
• Statisticians
– usually have at least an MSc
in statistics
• SAS Programmers
– usually have at least a BSc in
statistics, mathematics,
computing or any other degree
with a high level of numeracy
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Key Skills for a
Graduate Applicant
• Sound understanding of statistical
methodology and how to apply it
• Good communication and presentation
skills
• Can work well in a team and
independently
• An eye for detail
• Well organised
• Logical thinker
• Good statistical programming skills
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My Career to Date
• Educational Background
• Professional Experience
• Current Role
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To Summarise...
• Applying statistical techniques
learnt throughout your degree
to help improve health and
save lives
• Growth industry
• Good career prospects
• Excellent benefits and salary
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Other information available
Sponsorship
PSI
Event/Conferences
Person
Profiles
PSI
Careers Section
ABPI
Careers link
Placements
RSS
Careers link
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www.psiweb.org
E-mail Contact: [email protected]
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