Senior Director, Biostatistics

Senior Director of BiostatisticsJob Title: Senior Director of BiostatisticsDepartment: ClinicalReports To: CMOLocation: Remote or OnsitePOSITION SUMMARY:Atsena is seeking an experienced and highly motivated Senior Director of Biostatistics to lead ourBiostatistics, Data Management, and Clinical/Statistical Programming functions. This individual will beresponsible for developing and executing biometrics strategies that support the design, execution, andanalysis of clinical trials across all phases of drug development and commercialization. The idealcandidate will have a strong background in biometrics, regulatory compliance, and cross-functionalcollaboration within a biotech or pharmaceutical environment. This role reports to the Chief MedicalOfficer.Responsibilities:• Lead and manage biometrics functions (statistics, data management, clinical/statisticalprogramming) for all clinical development programs, ensuring alignment with the company'scorporate goals, scientific objectives, and regulatory requirementsDevelop and implement a strategy for biometrics resourcingEnsure overall high quality and effective operations in biometrics functions.Accountable for biometrics input in documentation including clinical development plans, clinicalprotocols, regulatory documents, publications, internal and external meetings, andpresentations.• Provide expertise in statistical methodology, regulatory submission strategies, and innovativedata analysis approaches for retinal disease gene therapy.• Accountable for the development, implementation and execution of statistical analysis plansthat support clinical development plans and clinical protocols, and assures statistical integrity,adequacy and accuracy.• Accountable for the development, implementation, and execution of randomization strategiesfor applicable clinical trials• Accountable for the selection, oversight, and documentation of vendors providing biometricsservices for clinical protocols.• Accountable for the set-up, oversight, and documentation of data deliverables from externalvendors providing data for clinical trials.• Collaborate with cross-functional teams to communicate resource needs, budget, timelines,data insights and biometrics strategies to internal stakeholders and external partners.• Establish best practices, identify the need and drive the creation of functional standardoperating procedures for clinical data management, biostatistics, and clinical/statisticalprogramming.• Participate in meetings with external experts and regulatory authorities to support safetyreviews, statistical endpoints, analyses and related issues.• Collaborate with researchers and thought leaders in the planning of clinical developmentprograms and the publication of study data.• Provide ad hoc analysis as needed for internal (including preclinical and CMC teams) andexternal stakeholders for strategic decision makingQualifications:Ph.D. in Biostatistics or StatisticsAt least 12 years biotech industry experience, including at least 5 years of leadership experienceat a pharma/biotech company• Experience directly leading/managing all aspects of biometrics (statistics, programming, anddata management)Experience working on a Phase III clinical program in Ophthalmology or Rare DiseaseExtensive experience in contributing to NDAs/BLAs submissions, including significant interactionwith both FDA, EMA, and PMDA• Experience applying principles and techniques of data analysis, interpretation, and clinicalrelevance in clinical drug development• Experience managing external CROs, vendors, and partners to ensure biometrics-relateddeliverables are high quality, on time and within budget.• Experience presenting data to internal management, external experts, and regulatorsRequired SkillsAbility to travel as neededCRO/Vendor management experienceFluent in English (written and spoken)Strong computer skills: Word, Excel, PowerPoint, Outlook, SmartsheetsExpertise in statistical methodology, clinical trial design, and regulatory requirements in thecontext of ocular gene therapy and/or other gene-based therapeutics.Expertise in clinical trial design, statistical modeling, and SAS/R programming.Expertise with setup and management of Data Management systems, e.g., Medidata Rave.Perseverance mindset with the ability to stick with a task during challenging timesStrong leadership skills and the ability to manage multiple projects independentlyStrong organizational, written and oral communication, tracking, and presentation skillsThe ability to handle multiple priorities within matrix environmentStrong problem-solving skillsProven track record of fostering creativity, productivity, execution with a sense of urgency,teamwork, accountability, and cross-functional collaboration• Team-builder who leads by example, employs expertise and influence to encouragecollaboration across departments, levels, and groups to achieve key objectives• Excellent collaboration required – needs the energy to work across global & functionalboundaries both internally and externally• Vision – keen awareness of R&D priorities to apply novel solutions to scientific problems