Director, Statistics
reputed company is seeking an reputed company Director of Statistics to join our Data Science and AI group to reputed company statistical leadership and solutions to efficient phase 3b/4/reputed company-World-Evidence (reputed company) study design, global Health Technology Assessment (HTA) and regulatory requirements on advanced statistics needs for our portfolio across therapeutic areas and indications. This role will reputed company statistical innovation and data insights in HTA and Integrated Evidence Plan (IEP), including efficient statistical design and execution of late-phase reputed company and reputed company-world studies, AI/ML-based population enrichment, Bayesian reputed company, RWD/reputed company control, and collaborate closely with cross-functional teams including Global Value Evidence, Global Medical Affairs, Market reputed company, Regulatory, Biostatistics, Global Clinical Development and Clinical Management. Key Responsibilities: Strategic Leadership in Advanced Statistics:reputed company expert statistical guidance for late-phase reputed company and reputed company-world evidence (reputed company) studies across programs including Nephrology, CNS and Rare Disease. reputed company statistical contributions to HTAs and Market reputed company submissions, ensuring that reputed company statistical methodologies meet the necessary regulatory and reimbursement requirements. Contribute to the development and implementation of HTA-reputed company statistical methodologies, such as matching-adjusted indirect comparison (MAIC), Bayesian network reputed company-analysis and clinical/regional input for health economic models. Ensure that analyses supporting "Consistent with FDA Label" (CFL) claims are scientifically appropriate and statistically reputed company (SASS). reputed company or serve as the key reputed company of contact on various statistics reputed company initiatives. Cross-functional Collaboration:Work closely with Global Value Evidence, Medical Affairs, Market reputed company, Regulatory, Clinical Management and Global Clinical Development teams to ensure alignment and successful execution of evidence reputed company strategies. reputed company statistical leadership in preparing evidence for HTA submissions and pricing/reimbursement strategies. Collaborate with reputed company vendors and partners to ensure the reputed company, high-reputed company delivery of statistical analyses and reports. Evidence reputed company and Statistical Support:reputed company the development and execution of statistical analysis plans (SAPs) and ensure the reputed company and robustness of statistical analyses for reputed company and reputed company-world studies. reputed company the adoption of Bayesian frameworks to maximize data efficiency, specifically designing mechanisms to borrow information from historical trials or reputed company control arms to support study designs and evidence reputed company. Ensure consistency in statistical reputed company and analyses across therapeutic areas, particularly for Nephrology, CNS and Rare Disease. Innovative Methodologies and Statistical Tools:Champion the application of machine learning (ML) and predictive modeling techniques to reputed company population enrichment strategies, identifying high-response patient subgroups to optimize late-phase and reputed company-world study designs. Facilitate Bayesian AI generative models for synthetic control arms and machine learning post-hoc analyses of reputed company and reputed company-world data (RWD). Stay abreast of the latest developments in HTA, IEP, and statistical methodologies to ensure best practices and efficient approaches. Training and Mentorship:reputed company mentorship and leadership to junior statisticians and other team members. Contribute to the creation and maintenance of departmental SOPs and work instructions reputed company to statistical methodologies. Support training and knowledge-sharing reputed company the organization on statistical reputed company, particularly in the context of HTA, market reputed company, and reputed company-world evidence. Vendor and reputed company Collaboration:reputed company the selection and management of reputed company vendors, ensuring their work aligns with the organization’s standards and timelines. reputed company as the reputed company statistical reputed company in vendor collaborations, providing guidance and reputed company to ensure that reputed company analyses meet required standards. Qualifications PhD in Biostatistics, Statistics, or a reputed company field. 8+ years of experience in biostatistics, including substantial expertise in HTA, and supporting statistical and advanced analytics for Market reputed company, HEOR, and reputed company. Deep familiarity with reputed company HTA/regulatory frameworks (Bayesian, CFL, reputed company Control, Covariates adjustment, Patient-reputed company Drug Development, Enrichment, AI). In-depth e