Associate Director, Biostatistics
Alira Health - Boston, MA
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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description SummaryJob DescriptionROLEThe Associate Director of Biostatistics provides statistical leadership in clinical development programs andor supports the VP of Biostatistics and Statistical Consulting to run the department to appropriate quality standards and in line with company strategy. KEY RESPONSABILITIES Leads the development and execution of statistical strategy in clinical trial development, including contribution to study trial design, analysis planning, conduct and validation, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publicationsSupervises the activities of other biostatisticians in terms of technical aspectsLeads the internal statistical team assigned and is accountable for the quality and timeliness of the deliveriesoutputs producedSupport the management of processes for biostatistical activities, including making recommendations, planning implementation and coordinating changesSupport the development and professional growth of the resources of the departmentRepresents statistics both internally and externally as requiredProvide support and participate to the development of proposals including Bid defense meetings as requiredProvide support and participate to audit inspections from regulatory agencies as requiredSupport the management of function KPIsSupport the organization and coordination of meetings with the members of the biostatistics department to share information and discuss issuesEnsures alignment of team members objectives with company strategies and objectivesProvides support for presentations to potential clientsRaises external profile of Alira Health biostatisticsConducts other activities as requiredDESIRED QUALIFICATION & EXPERIENCE PhD or Master's Degree in Statistics or related fieldAt least 10 years of relevant industry experience in BiostatisticsAt least 2 years of relevant industry experience in equivalent position with technical leadership andor managerial accountabilitiesAdvanced understanding of the pharmaceutical industry and the clinical development processAdvanced Knowledge of essential regulatory guidelines worldwideExpert knowledge of and competence in statistical methodology (i.e. trial design, inferential statistics statistical modelling...)Expert knowledge of ICH E9 Statistical Principles for Clinical TrialsTECHNICAL COMPETENCES & SOFT SKILLS Good Programming skills (SAS, R...)Excellent verbal and written communications skillsGood knowledge of MS Office SuiteStrong project management skillsStrong interpersonal skillsUnderstanding of international culturesProfessionalTrustworthyAbility to effectively prioritizeQuality focusedPersonable AttitudeWillingness to learnTeam PlayerEffective Stress Management TechniquesLearning AgilityAbility to Manage ConflictProblem Solving SkillsEffective Verbal Communication SkillsCommercial and Technical Writing SkillsNetworking SkillsAnalytical thinkingResilientAbility to Influence and motivateAbility to manage difficult conversationsAbility to Provide Constructive FeedbackExcellent Presentation SkillsCommercial awarenessAbility to recognize and develop talentLanguagesEnglishEducationDoctor of Philosophy (PhD): Statistics, Masters of Science (MS): StatisticsContract TypeRegular
Created: 2025-02-22