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hace 2 semanas

Xico, México Bebeepharmaceutical A tiempo completo

**Job Title:** Principal StatisticianWe are seeking an experienced Biostatistician with a passion for Real-World Evidence (RWE) and Real-World Data (RWD).The ideal candidate will have a strong background in statistical analysis, data management, and regulatory submissions.Key Responsibilities:- Design and execute statistical analyses using EHR, claims, registry, and observational data to support regulatory submissions and inform business decisions.- Lead RWE study design, including retrospective and pragmatic trials, to generate high-quality evidence for pharmaceutical companies.- Develop and validate models using programming languages like R, Python, SAS, and SQL to analyze complex datasets.- Support regulatory submissions to global authorities, such as the FDA and EMA, by communicating insights and results to cross-functional teams.Requirements:- A Ph.D. or M.S. in Statistics, Biostatistics, or a related field, with at least 5 years of experience in the pharmaceutical industry.- Proven experience in RWE/RWD analytics and regulatory submissions, with a strong understanding of causal inference, survival analysis, and longitudinal data.- Strong programming skills in languages like R, Python, SAS, and SQL, as well as experience with data management tools.- Familiarity with CDISC standards, such as SDTM, ADaM, and CDASH, as well as ICH GCP guidelines.Why Choose Us?- We offer a fully remote work environment with flexible schedules, allowing you to maintain a healthy work-life balance.- You'll collaborate with a global team of experts in the pharmaceutical industry, contributing to innovative therapies and meaningful healthcare outcomes.- Tailored development programs and career progression opportunities ensure your continued growth and success.If you're a skilled Biostatistician passionate about making data matter, we encourage you to apply todayKeywords: Biostatistics, Real-World Evidence, RWE, Real-World Data, RWD, Pharmaceutical Statistics, Healthcare Analytics, Statistical Analysis, Data Management, Regulatory Submissions, Pharmaceutical Industry

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