NicolaLittle(Schmitt)

Nicolalittle@alphamedicalstatistics.co.ukmobile+44(0)7599406653

Accomplished Statistician with expertise in study design, strategic development plans andrepresentingstatisticalviewstoworldwideregulatoryagencies.DevelopedtheTagrissoR(Oncology)studydesignsand representedAstraZenecaatFDAandEMAmeetings.AnalyticallymindedwithabreadthofexperienceacrossphasesItoIVandstatisticalleadforin-licensingandduediligence.KEYSKILLSTechnical Experience– utilisesSPLUS, SAS, R,NQuery, EAST to develop study design and analysedatatoimproveprecisionCollaborativeApproach–operatescross-functionallytodesignstudiesandinterpretinformation,providingsupportandguidancetocolleaguesCommunicationExcellence–translatescomplexconceptsintoinformationthatcanbereadilyunderstoodbynon-statisticiansOrganisationCapabilities–appliestime-managementtoensuresuccessfuloutcomeswhenmanagingmultipleprojects,statisticians,programmers,andinformationscientistsRegulatoryKnowledge–receivesacknowledgementfromcolleaguesthroughattendingregulatorymeetingsandprovidinginputtosubmissions

PROFESSIONALEXPERIENCE

StatisticalScienceDirectorandBiometricsTeamLeadforAstraZeneca(2004to22ndDec2016).Designandanalysisofclinicaltrials(phasesItoIV)andstrategicdevelopmentplans.

• Therapy areas include Oncology (immuno-oncology, lung, breast [advanced and neo-adjuvant],melanoma,uvealmelanoma,pancreatic,colorectal,gastriccancersandleukemia)andInfection

• RegulatoryexperiencewithFDA(TypeB,Cmeetings;3submissions),EMA(scientificadviceandsubmissions)andworldwideregulatoryauthorities

• DevelopedthestudydesignsandprogrammeforTagrissoR(FSItoUSapprovalin2yrs,8mo)andstatisticalleadforregulatoryinteractionswithFDAandEMA

• Statisticsleadforin-licensingandduediligenceintheHaemsarea

BiostatisticianforAdisEvidence,AdisInternationalCheshire(2003-2004),UK.ProvidedhealtheconomicandcompetitoranalysestothePharmaIndustry.

• Therapeuticareasincludedoncology,cardiovascular,andrespiratorymedicineBiostatistician. Medical Data Research Centre, Providence Health System, St Vincent Hospital,PortlandOR,USA(2001-2003).

• Analysedlargecardiothoracicdatasets• Leddesignandanalysisofstate-wideclusterrandomisedtrial,andprimarycarestudies

Biostatistician.DepartmentofCardiology,UniversityofWalesCollegeofMedicine,UK(1998–2001)

• ResearchStatisticianandUKco-ordinatorforamulti-centrestudy• Design and analysis of research projects within cardiology, pharmacology, and respiratory

medicine

CV-NicolaLittle(formerlySchmitt)EDUCATIONMasterofPhilosophy(MPhil),DepartmentsofMedicalStatisticsandCardiology,UniversityofWalesCollege of Medicine, UK. Thesis entitled “A multi-centre study of dobutamine stressechocardiographywith 'off-line'Dopplermyocardial imaging - anewmodality for thediagnosisofcoronaryarterydisease.”(1999-2001)

BScMathematicswithHonours(2.1),UniversityofWalesCollegeofCardiff.Content:statistics50%,puremathematics40%,andmechanics10%(1995-1998)A levels in Mathematics, Further Mathematics, German, and English Literature. BrockenhurstCollege,Brockenhurst,EnglandAwarded‘A’Levels(1993-1995)GCSEs. The Arnewood School, Hampshire. Awarded 13 GCSEs (12 Grade ‘A’) and an AS level inMathematics(1988-1993)EXTERNALPRESENTATIONS:

• DIA(Oct2016)-plenarypresentationonriskbasedmonitoring• PSI(May2016)–presentationonTagrisso• EFSPI,Brussels(2013)–“Missingdatainsurvivalanalysis”• RSSwebinar(2013)–“Attenuationoftreatmenteffectduetomeasurementvariabilityin

assessmentofprogression-freesurvival”• PSIconference(2012)–“VariabilitybyStealth”• PSIOnedayOncology(2012)–presentationonpredictingPIIIsuccess• PSIOnedayOncologymeeting(2010)–presentationofrecommendationsfromtheglobal

PhRMAPFSexpertteam• PSIposter(winner)andoralpresentationonmeasurementerrorandimpactonPFS(2010).[I

alsopresentedthisworktothePhRMAPFSexpertteamandrespondedtochallengefromthedifferentorganisations.PaperpublishedinPharmaceuticalstatistics]

• PSIconferenceplenaryDataAnalysissession(2009)–involvedanalysingasafetydatasetandpresentingrecommendationsinaplenarysession

OTHERSKILLSTeaching:LinemanagementandcoachingatAstraZeneca;deliveredmockstatsvivasforMembersoftheRoyalCollegeofPhysicians(MRCP)2002-2004 Other:German;CertifiedScubaDiver;climbing,running,swimmingREFEREEMrAndrewStone,Parklands,AlderleyPark,Macclesfield.CheshireSK104TF

SELECTEDPUBLICATIONS(publications.co.uk)1. Bettiol,E,Wetherington J,SchmittN. Challenges and Solutions for ClinicalDevelopment ofNewAntibacterial

Agents: Results of a Survey among Pharmaceutical Industry Professionals. Antimicrobial agents andchemotherapy2015;59:3695-3699

2. Stone A, Schmitt N. Can a treatment be licenced on the basis of post-treatment predictive biomarkers?PharmaceuticalStatistics2014;13,214-221

3. BernardG,FrancoisB,MiraJ-P,SchmittN.Evaluatingtheefficacyandsafetyoftwodosesofthepolyclonalanti-

tumornecrosis factor-α fragmentantibodyAZD9773 inadultpatientswith severe sepsisand/or septic shock:randomized,double-blind,placebo-controlledphaseIIbstudy*.CritCareMed201442(3):504-11

4. Hagop M. K, Giovanni M,.., Schmitt N et al. Stage I of a Phase 2 Study Assessing the Efficacy, Safety, and

Tolerability of Barasertib (AZD1152) Versus Low-Dose Cytosine Arabinoside in Elderly Patients With AcuteMyeloidLeukemia.Cancer2013;119(14):2611-9

5. JohnstonS,ChiaS,KilburnL.Fulvestrantvsexemestanefor treatmentofmetastaticbreastcancer inpatients

with acquired resistance to non-steroidal aromatase inhibitors – a meta-analysis of EFECT and SoFEA(CRUKE/03/021&CRUK/09/007).SanAntoniaBreastCancerSymposium2012

6. HongS,SchmittN,StoneS,DenneJ.AttenuationoftreatmentEffectDuetoMeasurementErrorinAssessment

ofProgression-FreeSurvival.PharmaceuticalStatistics2012;11:394-402

(maidenname:Payne)

7. HuntJS,SiemienczukJ,TouchetteD,PayneN.Impactofeducationalmailingonthebloodpressureofprimarycarepatientswithmildhypertension.JGenInternMed.2004;19(9):925.

8. SchmittM,QasemA,McEnieryCetal.Roleofnatriureticpeptidesinregulationofconduitarterydistensibility.

AmJPhysiolHeartCircPhysiol.2004;287(3):H1167-71.

9. FukeD,HuntJ,SiemienczukJ,EstoupM,CarrollM,PayneN,TouchetteD.Cholesterolmanagementofpatientswithdiabetesinaprimarycarepracticebasedresearchnetwork.AmJManagCare2004;10:130-6.

10. SchmittM,GunaruwanP,PayneNetal.Effectsofexogenousandendogenousnatriureticpeptidesonforearm

vascularfunctioninchronicheartfailure.ArteriosclerThrombVascBiol.2004;24(5):911-7.

11. DoshiSN,KiniA,KimMC,PayneN,KamranM,ShermanW,MarmurJD,SharmaSK. AComparativeStudyofRotationalAtherectomy inAcuteandStableCoronarySyndromes in theModernEra. Am JCardiol2003;92:1404-08

12. SchmittM, Broadley AJ, Nightingale AK,Payne N et al. Atrial Natriuretic Peptide regulates regional vascular

volumeandvenoustoneinhumans.ArteriosclerThrombVascBiol2003;23:1833-8

13. Fraser AG,PayneN,Mädler CF for theMYDISE Investigators. Feasibility and reproducibility of off-line tissueDoppler measurement of regional myocardial function during dobutamine stress echocardiography. Eur JEchocardiogr2003;4:43-53.

14. GrunkemeierGL,PayneN,JinR,HandyJRJr.Propensityscoreanalysisofstrokeafteroff-pumpcoronaryarterybypassgrafting.AnnThoracSurg2002;74:301-5.

15. ZamvarV,WilliamsD,HallJ,PayneN,CannC,YoungK,KarthikeyanS,DunneJ.AssessmentofNeurocognitive

Impairment after Off-Pump and On-Pump Techniques for Coronary Artery Bypass Graft Surgery: ProspectiveRandomizedStudy.BMJ2002;325:1268.

16. DoshiSN,McDowell IF,MoatSJ,PayneN,DurrantHJ,LewisMJ,GoodfellowJ.Folicacidimprovesendothelial

functionincoronaryarterydiseaseviamechanismslargelyindependentofhomocysteinelowering.Circulation

2002;105:22-6.17. ButchartEG,PayneN,LiHH,BuchanK,MandanaK,GrunkemeierGL.BetterAnticoagulationControlImproves

SurvivalAfterValveReplacement.JThoracCardiovascSurg2002;123:715-23.

18. Ashfield-Watt PAL, Knowles RM, Cole SB, Payne N, Ian FWMcDowell: A folate enriched diet lowers plasmahomocysteineinpatientswithhyperlipidaemia:arandomisedcontrolledtrial.TheBritishJournalofCardiology2001;8:28-35

19. Ionescu AA, Ionescu AA, Payne N, Obieta-Fresnedo I, Fraser AG, Shale DJ. Subclinical right ventricular

dysfunctionincysticfibrosis.AstudyusingtissueDopplerechocardiography.AmJRespirCritCareMed2001;163:1212-8.

20. GriffithsTL,BurrML,Campbell IA,Lewis-JenkinsV,Mullins J,ShielsK,Turner-LawlorPJ,PayneN,Newcombe

RG, Ionescu AA, Thomas J, Tunbridge J. Results at 1 year of outpatient multidisciplinary pulmonaryrehabilitation:arandomisedcontrolledtrial.Lancet2000;355:362-368.