We are seeking a highly motivated Associate Directorof Biostatistics; you will be required to influence and drive thestatistical strategy and innovation through strong collaborationsand decision making for assigned trials/programs within(pre/early/full) clinical development and/or medical affairs.Proven experience in supporting complex clinical trials and leadingstrategy through collaborations with partners across theorganization. About the Role Our Development Team is guided by ourpurpose: to reimagine medicine to improve and extend people’slives. To do this, we are optimizing and strengthening ourprocesses and ways of working. We are investing in new technologiesand building specific therapeutic areas and platform depth andcapabilities – all to bring our medicines to patients even faster.We are seeking key talent, like you, to join us and help givepeople with disease and their families a brighter future to lookforward to. Apply today and welcome to where we thrive together!The Role: We are seeking a highly motivated Associate Director ofBiostatistics; you will be required to influence and drive thestatistical strategy and innovation through strong collaborationsand decision making for assigned trials/programs within(pre/early/full) clinical development and/or medical affairs.Proven experience in supporting complex clinical trials and leadingstrategy through collaborations with partners across theorganization. Representing the Biostatistics and Pharmacometricsfunction both internally and externally on decision boards,developing and mentoring other statisticians, and providingsolutions to the organization. You may have the responsibility ofleading a team of up to 8 associates. This role offers hybridworking, requiring 3 days per week or 12 days per month in ourLondon Office. Key Requirements: - Responsible for all statisticaltasks on assigned clinical or non-clinical trials and perform thesetasks for high complexity trials with a high level of independenceseeking peer input/review as required. Responsible for protocoldevelopment in alignment with the development plan, developingstatistical analysis plan, and reporting activities. - Contributeto planning and execution of exploratory analyses, innovativeanalyses related to publications and pricing & reimbursementsubmission and/or PK, PK/PD analyses, exploratory biomarker anddiagnostic analyses, and statistical consultation. Initiate, drive,and implement novel methods and innovative trial designs anddose-finding strategies in alignment with the Lead Statistician. -Experience in providing statistical expertise to support submissionactivities, including documents, meetings with and responses toHealth Authorities, pricing agencies and drug developmentactivities, as required. - Independently lead interactions withexternal review boards/ethics committees, external consultants, andother external parties with oversight as appropriate. RepresentNovartis in statistical discussions at external congresses,conferences, scientific meetings. - Represent the Biostatistics& Pharmacometrics Line Function on cross-functional teams forthe assigned trials. Responsible for functional alignment andensuring line function awareness throughout the trials. -Collaborate with other line functions. Explain statistical conceptsin an easily understandable way to non-statisticians and provideadequate statistical justifications and interpretation of analysisresults for actions/decisions/statements, when required. -Establish and maintain sound working relationships and effectivecommunication within the clinical trial team and Biostatistics& Pharmacometrics team. - Independent oversight ofBiostatistics resources and deliverables for assigned trials.Ensure timeliness and adequate quality of all Biostatisticsdeliverables for the assigned trials and/or non-clinical relatedactivities. Your Experience: - MS Statistics with 10+ years’ workexperience or PhD (in Statistics or equivalent) with 6 years + workexperience - Fluent in English with strong communication andpresentation skills, with the ability to articulate complexconcepts to diverse audiences. - Effective utilization ofinnovative statistics and quantitative analytics to influenceassigned program team decisions and support department to deliverobjectives. - Proven knowledge and expertise in statistics and itsapplication to clinical trials. Depending on the assignment, mayrequire proven expertise in pharmacokinetics, exposure-responsemodelling, exploratory biomarker, diagnostic analyses, appliedBayesian statistics, or data exploration skills. Demonstratedexcellence in use of statistical software packages (e.g. SAS, R).Strong knowledge of drug development and Health Authorityguidelines. Experience independently leading a multidisciplinaryteam to achieve team objectives. Expert skills to facilitate andmaximize the contribution of quantitative team. Hands-on experiencein leading the interface to regulatory agencies/leading the earlyclinical development campaign. - Strong understanding ofFranchise/Therapeutic Area and or regulatory activities. Expertscientific leadership skills demonstrated in facilitating andoptimizing the (pre/early/full-) clinical development strategy.Strong track record for global scientific leadership in thedevelopment and evaluation of modern program/trial designmethodologies. - Demonstrated strong skills in buildingpartnerships and collaborations. Ability to mentor up to 8associates. Why Novartis: Helping people with disease and theirfamilies takes more than innovative science. It takes a communityof smart, passionate people like you. Collaborating, supporting,and inspiring each other. Combining to achieve breakthroughs thatchange patients’ lives. Ready to create a brighter future together?Commitment to Diversity & Inclusion: Novartis is committed tobuilding an outstanding, inclusive work environment and diverseteams' representative of the patients and communities we serve.Join our Novartis Network: Not the right Novartis role for you?Sign up to our talent community to stay connected and learn aboutsuitable career opportunities as soon as they come up. GB16 (FCRS =GB016) Novartis Pharmaceuticals UK Ltd. Functional Area Research& Development Job Type Full time Employment Type Regular ShiftWork No Novartis is committed to building an outstanding, inclusivework environment and diverse teams' representative of the patientsand communities we serve. #J-18808-Ljbffr
