Real World Biostatistician - RWE CMH experience

Biostatistician – Real-World Evidence (RWE) Location: Morrisville, NC, United States Job ID: 25109955-OTHLOC-1500-2DIL-2DR Job Responsibilities Design and execute real‑world evidence studies using EMR and claims data, including developing data specifications, statistical analysis plans, and study protocols. Develop and apply robust statistical methodologies such as causal inference methods (propensity score, weighting, matching, GLM/GLMM, MMRM, survival analysis, random forest), trial emulation frameworks, and external control arm development. Perform data analysis using healthcare coding systems (ICD, NDC) and conduct sample size estimation and power calculations for observational and hybrid study designs. Collaborate cross‑functionally with stakeholders in HEOR, Market Access, Regulatory, and Clinical Development teams. Translate complex analytical results into clear, actionable insights via presentations or study reports for decision‑making. Support methodological innovation in RWE, including integration of machine‑learning approaches where appropriate. Required Qualifications M.S. or Ph.D. in Biostatistics, Statistics, Epidemiology, or a related field. ≥5 years of experience in RWD/RWE analytics in industry or equivalent settings. Strong experience with EMR and/or claims data and proficiency in healthcare coding systems (ICD, 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, observational study design, sample size and power considerations. Experience writing cohort definitions in SQL, debugging data issues, and understanding concept mapping across vocabularies. RWE CMH experience. Preferred Qualifications Ph.D. strongly preferred. Experience in one or more therapeutic areas: Diabetes, Cardiovascular Disease, or Metabolic Disorders. Familiarity with trial emulation methodologies, external control borrowing/hybrid designs, and basic machine‑learning methods applied to RWD. Ability to work across multiple therapeutic areas in a fast‑paced environment. Strong communication and stakeholder engagement skills. Build reusable cohort pipelines and optimize queries for large‑scale databases. Experience working across multiple CDMs (OMOP, Sentinel, PCORnet). Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr