Director of Alumni Relations managing alumni engagement strategies at Clarke Schools. Developing programs and fostering connections with former students and their families.
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Hybrid Associate Director, Principal Statistician – Real-World Biostatistics
Posted 6 months ago
About the role
- 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
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