Associate Director/Principal Statistician driving strategic biostatistical initiatives in real-world evidence. Collaborating across teams to enhance decision-making for regulatory submissions and trial design.
Responsibilities
Lead the design and analysis of non-interventional studies, aligning with cross functional teams, managing timelines, and ensuring methodological rigor and quality control.
Apply statistical and RWD expertise to guide the selection and appropriate use of complex health data sets, co-develop variable definitions, code lists, and author technical specification documents.
Develop and refine statistical analysis plans, conduct complex statistical analyses, including for example causal inference, comparative effectiveness, target trial emulation, and communicate findings to internal and external stakeholders.
Serve as a senior-level RWB consultant within matrix teams, leveraging in-depth expertise on assigned assets.
Serve on enterprise level strategic initiatives, for example Disease Area Acceleration Teams, for organizational deliverables.
Present statistical analyses and insights effectively to internal stakeholders and external audiences, including conferences and publications, showcasing the value of biostatistical contributions.
Engage in strategic communication to reinforce the role of biostatistics in driving innovation and decision-making across the organization.
Stay informed on emerging industry trends and incorporate cutting-edge biostatistical methods to improve study designs and analytics.
Provide biostatistical expertise on RWD during regulatory submissions, preparing for meetings and addressing regulatory queries to ensure compliance with industry standards.
Requirements
Ph.D. in Statistics, Data Science, Epidemiology, or related field with 6+ years of experience (or Master’s degree with 8+ years) for Associate director (or for Principal Statistician PhD with 4+ years / Master’s degree with 3+ years) in the pharmaceutical/biotech industry, preferably in real-world evidence, epidemiology, or health outcomes research.
Experience working with drug development processes utilizing statistical skills to achieve project and business objectives.
Experience using RWD (e.g., electronic health records, insurance claims, registries) and applying observational study designs and biostatistical principles in clinical/epidemiological research.
Proficiency in programming languages R and SQL, with applied experience working with observational datasets.
Experience contributing to methodological research and publications in the field of biostatistics and real-world data analytics.
Experience working within regulatory frameworks related to RWD.
Experience in advanced biostatistical techniques, including causal inference, comparative effectiveness, time to event analysis, longitudinal and predictive modelling, and external control arms.
Familiarity with machine learning techniques and applications in real-world data analysis.
Demonstrated ability to manage complex projects and deliver high-quality results in dynamic environments.
Strong communication and interpersonal skills to effectively convey complex statistical concepts.
Fluency in written and spoken English.
Benefits
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Job title
Associate Director, Principal Statistician – Real-World Biostatistics
Business Accountability Director managing Exam Management Program at Wells Fargo. Ensuring organizational compliance, operational excellence, and accountability across regulatory and internal examinations.
Dynamic leader driving integrated customer experience across multiple teams for Data Center and Industrial clients. Responsible for planning, execution, and team development.
Director, Medical Information leading the function for delivering compliant scientific responses. Overseeing medical inquiry structure and ensuring high - quality medical information in biotech.
Senior Director managing development and implementation of integrated care management programs at IEHP. Focusing on person - centered care that addresses medical, behavioral, and social needs historically underserved populations.
Director of Materials Management overseeing material planning and inventory at Regal Rexnord. Ensuring supply chain efficiency and optimal inventory levels across North America manufacturing sites.
Director of Shopper Research managing accounts and delivering insights for data - driven decisions. Spearheading analytics and mentoring team members in a hybrid setting.
Director of Business Portfolio Management at Sun Life focusing on portfolio management and team leadership. Collaborating with stakeholders to drive strategic initiatives and reporting.
Senior Director leading European Wholesale strategy and partnerships for Crocs. Overseeing a multi - country team and driving revenue and brand sustainability goals.
Real Estate Development Director at Continental Properties driving execution of multifamily projects and leading cross - functional teams in Menomonee Falls, WI.