Careers for Statisticians and Statistical Programmers within the Pharmaceutical Industry

1. Careers for Statisticians and Statistical Programmers within the Pharmaceutical Industry Insert your name here

2. What is the Pharmaceutical Industry? • Develops medicines • Successful and growing industry • Pharmaceutical, Biotechnology and Medical Device companies • Contract Research Organisations

3. 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.

4. Drug Development Process Drug Discovery Pre-clinical Formulationdevelopment Clinical trials Manufacturing Sales & Marketing Marketing Authorisation

5. 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?

6. 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

7. 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

8. 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

9. Phase IV • After the drug has been licensed for prescription by doctors • To provide supporting data for further investigations • Marketing

10. 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

11. Pharmacy and Production • During Clinical Trials • Formulation Development • Assessing impurities and safety • Scaling up drug creation • Manufacturing

12. Where are Statisticians Involved? • Nonclinical Statistics • Drug Discovery • Safety/Toxicology • Pharmacy & Production • Manufacturing • Clinical Statistics • Phases I-IV • Licensing & Regulatory

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

14. 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 Clinical Trials Process – How is a Clinical Statistician involved? Input into Clinical Report

15. 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 Clinical Trials Process – How is a Statistical Programmer involved?

16. Interactions with People Internal CRAs Medical Writers Regulatory Epidemiologists Ethics committees Pharmacovigilence Medics Pharmacokinetics Academia Medical Sales External Data management Regulatory Project management

17. Opportunities • Management • People • Projects • Technical Expert • Consultant • Academia SAS Programmer/Statistician

18. Working Environment • Good career progression • Generous benefits and competitive salaries • Excellent working conditions • Professional environment • Continuing professional development • Opportunities for travel • PSI involvement

19. 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

20. 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

21. My Career to Date • Educational Background • Professional Experience • Current Role

22. 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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24. www.psiweb.orgE-mail Contact: Careers@psiweb.org