Director, Real-World Biostatistics

Role Summary

The Director, Real-World Biostatistics is a key role focused on advancing strategy and methodology in drug/vaccine development using real-world data (RWD). This position provides deep biostatistical expertise, strategic insight, and supports methodological innovation to enhance development and commercialization of pharmaceutical products, primarily in the oncology research unit. The role includes designing and analyzing RWD studies and mentoring staff, utilizing causal inference, comparative effectiveness, and other advanced biostatistical methods.

Responsibilities

• Lead and oversee the execution of real-world studies, ensuring methodological rigor, quality control, and regulatory adherence.
• Create and refine statistical analysis plans, conduct complex statistical analyses, and convey findings to internal and external stakeholders.
• Apply fit-for-purpose non-interventional statistical methods tailored to specific study objectives, ensuring robust data interpretation and insight generation.
• Understand RU/assets to apply appropriate tools and data sources, guide the selection and use of complex health data sets, and author technical specification documents.
• Develop in-depth knowledge on assigned assets and act as senior-level consultant on matrix teams.
• Mentor junior staff, guiding their capabilities through mentorship, training, and professional growth opportunities while promoting knowledge sharing and an innovative environment.
• Lead statistical efforts for assigned projects, manage timelines, resources, quality control, and coordinate across departments.
• Engage in strategic communication presenting statistical analyses and insights clearly at conferences, in publications, and during stakeholder meetings.
• Stay informed on industry trends, incorporate emerging biostatistical methods, and participate in methodological research for analytical techniques.
• Provide biostatistical expertise on RWD during regulatory submissions and ensure alignment with regulatory standards.

Qualifications

• Required: Ph.D. in Biostatistics, Statistics, Epidemiology or related disciplines with 8+ years (or Master's plus 10+ years) in the pharmaceutical/biotech industry, preferably in real-world evidence, epidemiology, or health outcomes.
• Required: Experience with drug development processes, innovative statistical skills to meet objectives.
• Required: Experience leading pharmacoepidemiology and/or health outcomes analytics using RWD, observational study design and biostatistical principles.
• Required: Proficiency in programming languages (R, Python) and applied experience with observational data.
• Required: Experience with regulatory requirements pertaining to RWD and clinical trials.
• Required: Experience managing projects in matrixed environments.
• Required: Experience in methodological research with publications in real-world data analytics.
• Preferred: Experience in causal inference methods (propensity scores, TMLE, principal stratification, instrumental variables, time-varying exposures).
• Preferred: Time-to-event analysis in non-randomized studies.
• Preferred: Experience in machine learning.
• Preferred: Excellent communication and interpersonal skills; fluent in English.

Skills

• Biostatistics
• Real-World Data analytics
• Observational study design
• Regulatory science
• Statistical programming (R, Python)
• Communication of complex statistical concepts

Education

• Ph.D. in Biostatistics, Statistics, Epidemiology or related field (preferred).