1. 29 July 2013
Presented by:
Swati M. Aute
(M. Pharm, SEM-II )
Department of Pharmaceutics
Supervised by:
Dr. J. I. D’souza
Principal
Guided by :
D. A. Bhagwat
(Assistant Professor)
Department of Pharmaceutics
Tatyasaheb Kore College of Pharmacy,
Warananagar

2.  Qualification
 Key skill for applicant
 Working environment
 Responsibilities
 Opportunities
 Role and Actual work
29 July 2013 1/16Tatyasaheb Kore College of Pharmacy, Warananagar

3. Statistician
 Degree in pharmacy
 Usually have at least an MSc in statistics
 Usually have at least a BSc in statistics,
mathematics, computing or any other degree
with a high level of knowledge about statistic.
29 July 2013 2/16Tatyasaheb Kore College of Pharmacy, Warananagar

4. 29 July 2013 3/16
Good communication and presentation skills
Can work well in a team and independently
Good statistical programming skill
Good understanding of statistical methodology
and how to apply it
Well organised
Logical thinker
Tatyasaheb Kore College of Pharmacy, Warananagar

5. 29 July 2013 4/16
Good career progression
Generous benefits and competitive salaries
Excellent working conditions
Continuing professional development
Opportunities for travel
PSI(statistician in pharmaceutical industry)
involvement
Tatyasaheb Kore College of Pharmacy, Warananagar

6. 29 July 2013 5/16
Sample size
calculation
Analysis of
planning and
reporting
Interpretation and
decision making
Tatyasaheb Kore College of Pharmacy, Warananagar

7.  In pharmaceutical company
 Biotech company
 CROs ( contract research organisation )
 Epidemiology
 Drug safety
 Risk assessment
29 July 2013 6/16Tatyasaheb Kore College of Pharmacy, Warananagar

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9.  The clinical development plans
 The clinical trial
 Analysis and presentation of result
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10. Where are Statisticians
Involved?
 Nonclinical Statistics
 Drug Discovery
 Pharmacy & Production
 Manufacturing
Pre-clinical
 Safety and toxicology
Clinical Statistics
 Phases I-IV
29 July 2013 9/16Tatyasaheb Kore College of Pharmacy, Warananagar

11. Drug
Discovery
Pre-clinical Formulation
development
Clinical trials
Manufacturing
Marketing
Authorization
Sales &
Marketing
Drug Development Process
29 July 2013 10/16Tatyasaheb Kore College of Pharmacy, Warananagar

12. Clinical Trials Process – How is a Clinical
Statistician involved?
Study Design and Protocol Development
Case Report Form Development
Data Validation Process
Writes Statistical Analysis Plan
Review of Blinded Tables and Listings
Database Lock
Interpretation and Presentation of results
29 July 2013 11/16Tatyasaheb Kore College of Pharmacy, Warananagar

13. 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
29 July 2013 12/16Tatyasaheb Kore College of Pharmacy, Warananagar

14. Emma Simmons
statistician CROs company
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A career as a statistician in the pharmaceutical
industry, whatever kind of company you choose to
work for, has much to offer: a diverse and challenging
future with plenty of opportunity to develop a variety
of skills,

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Useful organisations include the following.
Association of the British Pharmaceutical Industry
(ABPI): http://www.abpi.org.uk/
Statisticians in the Pharmaceutical Industry (PSI):
http://www.psiweb.org/
The European Federation of Statisticians in the
Pharmaceutical Industry (EFSPI):
http://www.efspi.org/
Drug
Tatyasaheb Kore College of Pharmacy, Warananagar

16. 29 July 2013 15/16
 Growth industry
 Good career prospects
 Excellent benefits and salary
The statistician have a very good oppotunities in
pharmaceutical industries
Tatyasaheb Kore College of Pharmacy, Warananagar

17. 29 July 2013Tatyasaheb Kore College of Pharmacy, Warananagar
 Humphries M, Niese D, Dai P. China as a growing research base
for innovation in medicines development. Int J Pharm Med.
2006;20: 355–359.
Procedu Yao C. Biostatistical guidelines for clinical trials in
China. Invited presentation at the 4th International Conference on
Multiple Comparison res, August 17–19, 2005,
`
 ICH Topic E9. Statistical Principles for Clinical Trials—Note
for Guidance on Statistical Principles for Clinical Trials, 1998.
Availableat:www.emea.europa.eu/pdfs/human/ich/036396en.pdf.
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