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

ja.2 What is the Pharmaceutical Industry? Develops medicinesDevelops medicines Successful and growing industrySuccessful and growing industry Pharmaceutical, Biotechnology and Medical Device companiesPharmaceutical, Biotechnology and Medical Device companies Contract Research OrganisationsContract Research Organisations

ja.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.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.If an agency is convinced that a drug works they will grant a license to market the drug in their country.

ja.4 Drug Development Process DrugDiscovery Pre-clinical Clinical trials MarketingAuthorisation Sales & Marketing Manufacturing Formulation development

ja.5 Discovery/Pre-clinical Target identificationTarget identification Creation and screening of new and old drugsCreation and screening of new and old drugs Testing of 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?

ja.6 Phase I Check that the pre-clinical findings are still true in manCheck that the pre-clinical findings are still true in man Small sample of healthy volunteersSmall sample of healthy volunteers Volunteers are closely monitoredVolunteers are closely monitored Pharmacodynamics and PharmacokineticsPharmacodynamics and Pharmacokinetics SafetySafety

ja.7 Phase II First time given to patientsFirst time given to patients Aim to show efficacyAim to show efficacy Look at range of doses to find therapeutic windowLook at range of doses to find therapeutic window Usually larger than Phase I studiesUsually larger than Phase I studies Usually longer duration than Phase I studiesUsually longer duration than Phase I studies Usually only 2 or 3 studiesUsually only 2 or 3 studies SafetySafety

ja.8 Aim to provide enough evidence to show regulatory authorities that the drug works and is safe.Aim to provide enough evidence to show regulatory authorities that the drug works and is safe. Larger multi-centre studiesLarger multi-centre studies Longer duration than Phase IILonger duration than Phase II At least 2 confirmatory studies (1 US, 1 ROW)At least 2 confirmatory studies (1 US, 1 ROW) Long Term SafetyLong Term Safety Pharmacokinetics e.g. drug interaction, food effect etc.Pharmacokinetics e.g. drug interaction, food effect etc. Licence applicationLicence application Phase III

ja.9 Phase IV After the drug has been licensed for prescription by doctorsAfter the drug has been licensed for prescription by doctors To provide supporting data for further investigationsTo provide supporting data for further investigations MarketingMarketing

ja.10 Licensing and Regulatory Food and Drug Administration (FDA) – USFood and Drug Administration (FDA) – US European Medicines Evaluation Agency (EMEA) - EUEuropean Medicines Evaluation Agency (EMEA) - EU Ministry of Health and Welfare (MHW) – JapanMinistry of Health and Welfare (MHW) – Japan Medicines and Healthcare products Regulatory Authority (MHRA) - UKMedicines and Healthcare products Regulatory Authority (MHRA) - UK

ja.11 Pharmacy and Production During Clinical TrialsDuring Clinical Trials –Formulation Development –Assessing impurities and safety –Scaling up drug creation ManufacturingManufacturing

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

ja.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

ja.14 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

ja.15 Clinical Trials Process – H ow is a Statistical Programmer involved? Case Report Form Development Data Validation and QC Review Statistical Analysis Plan Database Lock Production of Final Tables and Listings Provide Support to Medical Writers Table production based on blinded data Pooling Studies for Regulatory Submissions Support to Regulatory Documents and Queries Software Development

ja.16 Interactions with People Internal Regulatory CRAs Academia Ethicscommittees Medics Regulatory External Projectmanagement Sales Pharmacokinetics Datamanagement Epidemiologists Medical Writers Pharmacovigilence Medical

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

ja.18 Working Environment Good career progressionGood career progression Generous benefits and competitive salariesGenerous benefits and competitive salaries Excellent working conditionsExcellent working conditions Professional environmentProfessional environment Continuing professional developmentContinuing professional development Opportunities for travelOpportunities for travel PSI involvementPSI involvement

ja.19 Qualifications StatisticiansStatisticians –usually have at least an MSc in statistics SAS ProgrammersSAS Programmers –usually have at least a BSc in statistics, mathematics, computing or any other degree with a high level of numeracy

ja.20 Key Skills for a Graduate Applicant 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 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

ja.21 My Career to Date Educational BackgroundEducational Background Professional ExperienceProfessional Experience Current RoleCurrent Role

ja.22 To Summarise... Applying statistical techniques learnt throughout your degree to help improve health and save livesApplying statistical techniques learnt throughout your degree to help improve health and save lives Growth industryGrowth industry Good career prospectsGood career prospects Excellent benefits and salaryExcellent benefits and salary

ja.23 Other information available ABPI Careers link RSS PSIEvent/Conferences PSI Careers Section PersonProfiles Sponsorship Placements

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