1. Careers for Statisticians within the Pharmaceutical Industry

2. About PSI “PSI's purpose is to promote and lead statistical thinking in the Pharmaceutical Industry” www.psiweb.org Training Annual conference Scientific meetings Publications Careers Regulatory Stats. Computing Expert groups Collaborations Follow us on Twitter @PSIUpdate

3. The 2 nd biggest contributor to the GDP (after the finance industry) in the UKThe 2 nd biggest contributor to the GDP (after the finance industry) in the UK Approximately 72,000 people work in the pharmaceutical industry in the UKApproximately 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.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)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)Reimbursement decisions are made by the National Institute for Health & Clinical Excellence (NICE) The Pharmaceutical Industry in the UK *ONS Annual Business Inquiry and R & D Survey (2009).

4. Aims of the Pharmaceutical Industry Discover new medicines for prevention and/or treatment of diseasesDiscover new medicines for prevention and/or treatment of diseases Improve on medicinesImprove on medicines New devicesNew devices Methods of diagnosisMethods of diagnosis Better educationBetter education All of these fall under the umbrella of ‘Drug Development’ – and this is primarily where statisticians are involved

5. Stages of the Drug Development Process Discovery Clinical Development Post Marketing Surveillance Pre-Clinical Development

6. But the odds are against us…

7. What is the cost? Post Approval Confirm Filing Proof of Concept First in Human Dose Finding Phase DescriptionNumber*Duration* Cost* IFirst in Human101.5 y$100 M IIPOC/Dose Finding51.5 y$200 M IIIConfirm22.5 y$500 M IVApproved11.5 y$ 220 M Total1/107 y$1020 M * Average Values Kola and Landis. Nature Rev Drug Discovery 2004;3:711.

8. The Drug Development Roadmap

9. 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

10. 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

11. How is a Clinical Statistician involved? - Trial Design Involved right from the beginning of a trial.Involved right from the beginning of a trial. Help determine the design, objectives and endpoints for a trial.Help determine the design, objectives and endpoints for a trial. Sample size calculation.Sample size calculation. Protocol – outlines how the trial will be run and analysed.Protocol – outlines how the trial will be run and analysed. Randomisation scheme and blinding.Randomisation scheme and blinding. Case Report Form (CRF) development – to ensure the correct data are collected.Case Report Form (CRF) development – to ensure the correct data are collected.

12. How is a Clinical Statistician involved? - Analysis and Reporting Pre-specify key study analyses.Pre-specify key study analyses. While the study is running, statisticians sometime run analyses and also review the data coming in.While the study is running, statisticians sometime run analyses and also review the data coming in. At the end of a study the statisticianAt 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).

13. Must state our intentions upfront 13 PROTOCOL ANALYSIS PLAN ANALYSIS REPORT Say what we are going to do Do what we said we were going to do before seeing data Verify we have done what we said we were going to do

14. Our day-to-day work Writing statistical analysis plans.Writing statistical analysis plans. Discussing plans for analyses with clinicians and programmersDiscussing plans for analyses with clinicians and programmers Attending project meetingsAttending project meetings Design work for new studiesDesign work for new studies Reviewing study reportsReviewing study reports Responding to questions from regulatorsResponding to questions from regulators Performing exploratory analysesPerforming exploratory analyses Resolving differences in interpretation of programming specifications between the programmer and validator.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

15. Does the drug hit the target (e.g. tumour/ receptor)? Who and what diseases are we aiming to treat? Whether it will work and be safe in a wider population? Which compounds to progress further? How we can differentiate from other medicines? We use statistics to help inform and understand… The bigger picture… Once it’s at the target does it do anything we can measure?

16. Some of the other things you might get asked to do… Present at an investigator meetingPresent at an investigator meeting Attend conferences (both statistical and clinical)Attend conferences (both statistical and clinical) Training – SAS, S-PLUS/R, new statistical methodologies, consultancy skills…Training – SAS, S-PLUS/R, new statistical methodologies, consultancy skills… Presenting technical plans to senior management (e.g. plans for an interim analysis)Presenting technical plans to senior management (e.g. plans for an interim analysis) Help promote statistics in local schoolsHelp promote statistics in local schools Help design clinical trials using novel statistical methodsHelp design clinical trials using novel statistical methods Involvement in strategic decision makingInvolvement in strategic decision making Talk to students!Talk to students!

17. Programmers Interactions with People Within the company Academia Ethicscommittees Medics Regulatory Outside the company Regulatory CRAs Projectmanagement Sales Pharmacokinetics Datamanagement Epidemiologists Medical Writers Pharmacovigilence Medical

18. 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

19. 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!

20. 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

21. Key Skills for a Statistician Sound understanding of statistical methodology and how to apply itSound understanding of statistical methodology and how to apply it Good communication and presentation skillsGood communication and presentation skills Must be confident, competent, challenging – speak-up & influenceMust be confident, competent, challenging – speak-up & influence Can work well in a team and independentlyCan work well in a team and independently An eye for detailAn eye for detail Well organisedWell organised Logical thinkerLogical thinker Good statistical programming skillsGood statistical programming skills 20 Top Tips to get a Job20 Top Tips to get a Job20 Top Tips to get a Job20 Top Tips to get a Job

22. Role of a Programmer Produce analysis data sets, tables, figures and data listings predominantly using SAS ®Produce analysis data sets, tables, figures and data listings predominantly using SAS ® Create standard macros and applications for internal company useCreate standard macros and applications for internal company use Assist in the production of analysis plansAssist in the production of analysis plans Assist in the production of analysis data set specificationsAssist in the production of analysis data set specifications 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.

23. Qualifications Statistician Undergraduate degree (or equivalent) in Mathematics/Statistics or another relevant disciplineUndergraduate degree (or equivalent) in Mathematics/Statistics or another relevant discipline Postgraduate degree in StatisticsPostgraduate degree in Statistics Programmer Undergraduate degree (or equivalent) in a relevant discipline, Other undergraduate degree with relevant work experience

24. 31-3617ja.24 Working Environment Good career progressionGood career progression You are the expert, the specialist, the teacher. Never stop learning Large variety of work Generous benefits and competitive salariesGenerous benefits and competitive salaries Excellent working conditionsExcellent working conditions Always part of a team You make a real differenceYou make a real difference

25. Other Information Available PSIEvent/Conferences ABPI* Careers link RSS PersonProfiles PSI Careers Section Companies *The Association of the British Pharmaceutical Industry – www.abpi.org.uk www.MHRA.gov.uk

26. www.psiweb.org/careers www.psiweb.org/careers For questions or to provide feedback E-mail : Careers@psiweb.org Follow us on Twitter @PSIUpdate Further information is available under the ‘Careers’ dropdown menu on the PSI website homepage