Biostatistician, Safety Experience

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Design and implement real-world evidence (RWE) studies utilizing EMR and claims data.

• Develop data specifications, statistical analysis plans (SAPs), and protocols aligned with key research objectives.

• Create and apply robust statistical methodologies, such as causal inference, generalized linear/mixed models, repeated measures, survival analysis, and random forest techniques.

• Utilize trial emulation frameworks.

• Develop external control arms and borrowing strategies.

• Conduct data analysis using healthcare coding systems, including ICD and NDC.

• Perform sample size estimations and power calculations for observational and hybrid study designs.

• Collaborate with HEOR, Market Access, Regulatory, and Clinical Development teams.

• Translate intricate analytical results into clear, actionable insights presented through PowerPoint or study reports.

• Contribute to methodological innovations in RWE, integrating machine learning where applicable.

• Independently formulate cohort definitions using SQL logic and troubleshoot data issues.

• Convert statistical estimands into censoring rules and data extraction logic.

⛳️ Requirements

• M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related discipline.

• Minimum of 5 years of experience in RWD/RWE analytics (industry or equivalent).

• Extensive experience with EMR and/or claims data.

• Proficient in healthcare coding systems such as ICD and NDC.

• Programming skills in at least one of SAS, R, or Python.

• Familiarity with SQL logic and OMOP data structures.

• Strong understanding of causal inference methods.

• Solid grasp of observational study design principles.

• Well-versed in sample size and power considerations.

• Knowledge of trial emulation methodologies.

• Awareness of external control borrowing and hybrid design strategies.

• Basic understanding of machine learning methods as applied to RWD.

• Proven ability to operate across various therapeutic areas in a fast-paced environment.

• Excellent communication and stakeholder engagement skills.

• Advanced experience in building reusable cohort pipelines, optimizing queries for large-scale databases, or working with OMOP, Sentinel, and PCORnet is preferred but not mandatory.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive rewards program.

• An inclusive company culture.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave provisions.

• Reasonable accommodations available when appropriate.