Biostatistician, Safety Experience

Job Description:

• Design and execute real-world evidence (RWE) studies using EMR and claims data
• Conduct data specifications, statistical analysis plans (SAPs), and protocols with key research objectives
• Develop and apply robust statistical methodologies, including causal inference, generalized linear/mixed models, repeated measures, survival analysis, and random forest
• Apply trial emulation frameworks
• Develop external control arms and borrowing strategies
• Perform data analysis using healthcare coding systems such as ICD and NDC
• Conduct sample size estimation and power calculations for observational and hybrid study designs
• Collaborate with HEOR, Market Access, Regulatory, and Clinical Development stakeholders
• Translate complex analytical results into clear, actionable insights through PowerPoint presentations or study reports
• Support methodological innovation in RWE, including machine learning integration where appropriate
• Independently write cohort definitions in SQL logic and debug data issues
• Translate statistical estimands into censoring rules and data extraction logic

Requirements:

• M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or related field
• ≥5 years of experience in RWD/RWE analytics (industry or equivalent)
• Strong experience with EMR and/or claims data
• Proficiency in healthcare coding systems such as ICD and NDC
• Programming expertise in at least one of SAS, R, or Python
• Working knowledge of SQL logic and OMOP data structures
• Solid understanding of causal inference methods
• Solid understanding of observational study design
• Solid understanding of sample size and power considerations
• Familiarity with trial emulation methodologies
• Familiarity with external control borrowing and hybrid designs
• Basic machine learning methods applied to RWD
• Demonstrated ability to work across multiple therapeutic areas in a fast-paced environment
• Strong communication and stakeholder engagement skills
• Advanced experience building reusable cohort pipelines, optimizing queries for large-scale databases, or working across OMOP, Sentinel, and PCORnet is nice-to-have, not always required

Benefits:

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture
• Company car or car allowance
• Medical, Dental and Vision health benefits
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO)
• Sick time
• Reasonable accommodations, when appropriate