We are seeking an experienced Principal Biostatistician Consultant to provide statistical leadership for Medical Affairs and Real-World Evidence (RWE) initiatives. This is a high-impact consulting opportunity for a seasoned biostatistician who enjoys partnering with cross-functional stakeholders to generate meaningful evidence that informs medical, commercial, and market access strategies.
In this role, you will contribute to the design, analysis, and interpretation of observational studies, external and synthetic control analyses, meta-analyses, and causal inference methodologies supporting post-marketing evidence generation.
What You'll Do
• Provide statistical leadership for Medical Affairs and Real-World Evidence (RWE) programs.
• Partner with Medical Affairs teams on publication strategies and evidence-generation initiatives.
• Support HEOR and economic modeling activities through statistical expertise and analytical insights.
• Design and review real-world evidence study protocols.
• Conduct and oversee analyses involving:
• External Control Arms
• Synthetic Control Arms
• Meta-Analyses
• Causal Inference Methodologies
• Propensity Score Matching
• Collaborate with HEOR teams to ensure alignment with Health Technology Assessment (HTA) requirements.
• Develop Statistical Analysis Plans (SAPs).
• Create TLF shells and review programming specifications.
• Partner with statistical programmers to conduct ad hoc analyses and perform quality reviews.
• Contribute to manuscripts, abstracts, scientific publications, and conference presentations.
• Review relevant medical and scientific literature to support evidence-generation activities.
Qualifications
Required
• MS or PhD in Biostatistics or a related quantitative discipline.
• Minimum of 5 years of experience within the pharmaceutical, biotechnology, CRO, or related industry.
• Prior experience supporting Medical Affairs initiatives.
• Experience collaborating with Commercial and cross-functional stakeholders.
• Strong understanding of:
• Real-World Evidence (RWE)
• Observational Research
• Meta-Analyses
• Causal Inference Methodologies
• Propensity Score Methods
• External and Synthetic Control Analyses
• Familiarity with regulatory guidance related to RWE and Health Technology Assessment (HTA) requirements.
• Strong statistical programming capabilities using industry-standard statistical software.
• Excellent analytical, communication, and problem-solving skills.
• Ability to explain complex statistical concepts to non-statistical audiences.
• Strong commitment to data quality, scientific rigor, and Good Clinical Practice (GCP).
Preferred
• Oncology experience.
• Experience supporting payer evidence-generation strategies.
• Background in HEOR and market access analytics.
• Publication and scientific presentation experience.
Why This Opportunity?
This role offers the opportunity to work on highly visible evidence-generation initiatives that influence medical, scientific, and healthcare decision-making. You'll collaborate with Medical Affairs, HEOR, Clinical Development, and Commercial teams while applying advanced statistical methodologies to answer meaningful real-world questions.
Compensation
Compensation will be discussed directly with qualified candidates. Applicants will be asked to provide their desired compensation range as part of the interview process.
If you have deep expertise in Medical Affairs, Real-World Evidence, causal inference, and advanced biostatistical methodologies, we'd love to hear from you.