Transcript University Careers Talk Slides

Careers for Statisticians
within the Pharmaceutical
Industry
About PSI
“PSI's purpose is to promote and lead
statistical thinking in the Pharmaceutical
Industry”
• Careers
• Training
• Regulatory
• Annual conference
• Stats. Computing
• Scientific meetings
• Expert groups
• Publications
• Collaborations
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The Pharmaceutical Industry in the UK
• The 2nd biggest contributor to the GDP (after the finance
industry) in the UK
• Approximately 72,000 people work in the pharmaceutical
industry in the UK
– with about 27,000 of these in Research and
Development*
• Other areas are: Manufacturing, Regulatory Affairs, Sales
and Marketing.
• A highly regulated industry – within the UK this is through
MHRA (Medicines and Healthcare products Regulatory
Agency)
• Reimbursement decisions are made by the National
Institute for Health & Clinical Excellence (NICE)
*ONS Annual Business Inquiry and R & D Survey (2009).
Aims of the Pharmaceutical Industry
• Discover new medicines for prevention
and/or treatment of diseases
• Improve on medicines
• New devices
• Methods of diagnosis
• Better education
All of these fall under the umbrella of ‘Drug
Development’ – and this is primarily where
statisticians are involved
Stages of the Drug
Development Process
Discovery
Post Marketing Surveillance
Pre-Clinical Development
Clinical Development
But the odds are against us…
What is the cost?
First in
Human
Proof of
Concept
Dose
Finding
Phase Description
Confirm
Filing
Post
Approval
Number* Duration*
Cost*
I
First in Human
10
1.5 y
$100 M
II
POC/Dose Finding
5
1.5 y
$200 M
III
Confirm
2
2.5 y
$500 M
IV
Approved
1
1.5 y
$ 220 M
1/10
7y
$1020 M
Total
* Average Values
Kola and Landis. Nature Rev Drug Discovery 2004;3:711.
The Drug Development Roadmap
What Areas Do We Work In?
• The majority work in Phase I-IV Clinical Trials.
• However, statisticians also work in non-clinical
statistics.
• In areas such as:
–Drug Discovery
–Safety/Toxicology
–Pharmacy & Production
–Manufacturing
• Statisticians also work for Regulatory Authorities
–MHRA in the UK
Types of Company
• Can be small local companies to large multinationals
• Basic work is similar, but there could be a different
focus.
• Range of locations and facilities
• Pharmaceutical Companies
– Clinical
– Non-Clinical
• Clinical Research Organisations
– Clinical
– Non-Clinical
• Regulatory Authorities
– MHRA Statistical Assessors
How is a Clinical Statistician involved?
- Trial Design
• Involved right from the beginning of a trial.
• Help determine the design, objectives and
endpoints for a trial.
• Sample size calculation.
• Protocol – outlines how the trial will be run and
analysed.
• Randomisation scheme and blinding.
• Case Report Form (CRF) development – to
ensure the correct data are collected.
How is a Clinical Statistician involved?
- Analysis and Reporting
• Pre-specify key study analyses.
• While the study is running, statisticians
sometime run analyses and also review the data
coming in.
• At the end of a study the statistician
– Analyses the data and…
– Is the first to know the results of whether the
drug has worked!
– Helps interpret and present the results,
– Writes up the results,
– Provides input into the clinical study report,
– May be involved in publications of study
results (manuscripts, posters etc).
Must state our intentions upfront
PROTOCOL
Say what we are going to do
ANALYSIS PLAN
Do what we said we were
going to do before seeing data
ANALYSIS
REPORT
Verify we have done what
we said we were going to do
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Our day-to-day work
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Writing statistical analysis plans.
Discussing plans for analyses with clinicians and programmers
Attending project meetings
Design work for new studies
Reviewing study reports
Responding to questions from regulators
Performing exploratory analyses
Resolving differences in interpretation of programming
specifications between the programmer and validator.
How graduate statisticians spend their time
- Face to face discussion, as well as teleconferences
- Email, PC based programming (SAS)
- Regular discussions with supervisor
- Group Meetings with other Statisticians
- Ongoing technical training
The bigger picture…
Which
compounds to
progress
further?
Does the drug
hit the target
(e.g. tumour/
receptor)?
We use statistics
to help inform and
understand…
How we can
differentiate from
other medicines?
Whether it will work
and be safe in a
wider population?
Once it’s at the
target does it
do anything we
can measure?
Who and what
diseases are
we aiming to
treat?
Some of the other things you might get
asked to do…
• Present at an investigator meeting
• Attend conferences (both statistical and clinical)
• Training – SAS, S-PLUS/R, new statistical
methodologies, consultancy skills…
• Presenting technical plans to senior management
(e.g. plans for an interim analysis)
• Help promote statistics in local schools
• Help design clinical trials using novel statistical
methods
• Involvement in strategic decision making
• Talk to students!
Interactions with People
CRAs
Medical Writers
Epidemiologists
Pharmacovigilence
Medical
Regulatory
Regulatory
Medics
Ethics
committees
Academia
Pharmacokinetics
Sales
Project
management
Data
management
Within the
company
Outside the
company
Programmers
How is a Clinical Statistician involved?
- MHRA
• Review of applications for ‘Marketing
Authorisation’.
– Assessment of clinical trial methodology and strength of
evidence for efficacy
– Contributing to the decision on whether a medicine
should be licensed for use in the UK
• Agreeing standards for drug development with
pharmaceutical companies through ‘Scientific
Advice’
• Training of Medical Assessors in clinical trial
methodology
Upcoming/Current Trends
1.
Move from ‘Blockbusters’ to personalized/tailored
medicine
2.
Increase in sales/sales growth in emerging markets
(Brazil/ China/ Russia/India)
3.
Public access to clinical research data and increased
use of Real World Data
• Patients questioning therapies more (internet)
Others
•
•
•
•
Aging population therapies
Diabetes, oncology, Alzheimer's
More outsourcing and use of external partners
Networking with outside world – share more!
Challenges for the future
1.
Finding innovative drugs efficiently
• Need for stronger risk:benefit and cost:benefit
ratios
• Power shift towards Payers and Patients
2.
Escalating cost of drug development
• Expected mergers
• Speed of drug development needing to increase
3.
Loss of patents and onset of generics
4.
Higher regulatory hurdles
Key Skills for a Statistician
• Sound understanding of statistical methodology
and how to apply it
• Good communication and presentation skills
• Must be confident, competent, challenging –
speak-up & influence
• Can work well in a team and independently
• An eye for detail
• Well organised
• Logical thinker
• Good statistical programming skills
• 20 Top Tips to get a Job
Role of a Programmer
To ensure accurate & timely production of reports
and figures summarising the conduct of the clinical
trial and to advise on all aspects of the flow of data
from source to report.
• Produce analysis data sets, tables, figures and data
listings predominantly using SAS®
• Create standard macros and applications for internal
company use
• Assist in the production of analysis plans
• Assist in the production of analysis data set
specifications
Qualifications
Statistician
Programmer
• Undergraduate degree (or
equivalent) in
Mathematics/Statistics or
another relevant discipline
• Postgraduate degree in
Statistics
• Undergraduate degree (or
equivalent) in a relevant
discipline,
• Other undergraduate
degree with relevant work
experience
Working Environment
• Good career progression
• You are the expert, the specialist, the
teacher.
• Never stop learning
• Large variety of work
• Generous benefits and competitive
salaries
• Excellent working conditions
• Always part of a team
• You make a real difference
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Other Information Available
PSI
Careers Section
www.MHRA.gov.uk
PSI
Event/Conferences
ABPI*
Careers link
Person
Profiles
Companies
RSS
Careers link
*The Association of the British Pharmaceutical Industry – www.abpi.org.uk
Further information is available
under the ‘Careers’ dropdown
menu on the PSI website
homepage
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www.psiweb.org/careers
For questions or to provide feedback
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