Principal Biostatistician – Medical Affairs & RWE | Remote
Principal Biostatistician Consultant – Medical Affairs & Real-World Evidence (RWE) Shape the Future of Healthcare Through Real-World Evidence We are seeking a Principal Biostatistician Consultant to support advanced Medical Affairs and Real-World Evidence (RWE) initiatives. This role is designed for an experienced biostatistician who enjoys applying sophisticated statistical methods to generate meaningful insights that inform medical, scientific, and market access strategies. Location: 100% Remote (United States) Compensation: $130,000 – $180,000 (DOE)
Key Responsibilities
- Provide statistical leadership for Medical Affairs and RWE programs.
- Design and oversee observational studies and post-marketing evidence-generation initiatives.
- Lead analyses involving:
- External Control Arms
- Synthetic Control Arms
- Meta-Analyses
- Causal Inference Methods
- Propensity Score Matching
- Collaborate with Medical Affairs, HEOR, and cross-functional stakeholders.
- Develop Statistical Analysis Plans (SAPs) and review analytical outputs.
- Support scientific publications, abstracts, and conference presentations.
- Ensure alignment with RWE regulatory guidance and Health Technology Assessment (HTA) requirements.
Qualifications
Required
- MS or PhD in Biostatistics, Statistics, Epidemiology, or related quantitative field.
- 5+ years of experience in pharmaceutical, biotechnology, CRO, or healthcare environments.
- Prior experience supporting Medical Affairs initiatives.
- Strong expertise in:
- Real-World Evidence (RWE)
- Observational Research
- Meta-Analysis
- Causal Inference
- External and Synthetic Control Analyses
- HEOR and HTA-related evidence generation
- Strong statistical programming and analytical skills.
- Excellent communication and stakeholder management abilities.
- Ability to translate complex statistical concepts for non-technical audiences.
Preferred
- Oncology experience.
- Experience in payer evidence-generation or market access strategies.
- Publications and scientific presentation experience.
Why This Opportunity?
- High-impact consulting engagement in advanced evidence generation.
- Opportunity to work on meaningful real-world healthcare questions.
- Cross-functional collaboration with Medical Affairs and HEOR teams.
- Remote flexibility within the United States.
- Exposure to cutting-edge statistical methodologies in healthcare research.
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