Senior Biostatistician

Life Science People
  • Post Date: October 6, 2024
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Job Overview

logoJob Title: Senior Biostatistician – Real World Evidence (RWE)
About Us: Life Science People are working with a leading innovator in biotechnology, dedicated to advancing patient care and outcomes through cutting-edge research and data-driven insights. We are committed to leveraging real-world evidence to drive informed decision-making and improve the quality of care. Join us in our mission to make a meaningful impact on the future of healthcare.
Position Overview: We are seeking a highly skilled and experienced Senior Biostatistician with a strong background in Real World Evidence (RWE) to join our dynamic team. The ideal candidate will have extensive experience in designing and analyzing observational studies, utilizing real-world data to generate actionable insights, and collaborating with cross-functional teams to support strategic initiatives. This role requires a deep understanding of statistical methodologies, expertise in RWE, and a passion for translating complex data into meaningful recommendations.
Key Responsibilities: Study Design & Analysis: Lead the design and implementation of statistical analyses for RWE studies, including observational studies, registry analyses, and patient-level data analyses.Develop and validate statistical models to analyze complex datasets, ensuring robustness and accuracy of results.Provide expert guidance on study design, sample size estimation, and data analysis plans.Data Management & Integration: Oversee the integration and management of diverse real-world data sources, including electronic health records (EHRs), claims data, registries, and patient surveys.Ensure data quality, consistency, and compliance with regulatory requirements.Collaboration & Communication: Work closely with clinical researchers, epidemiologists, and data scientists to align statistical approaches with research objectives.Present findings to internal stakeholders, including senior management, and contribute to the development of strategic recommendations based on RWE.Prepare and review statistical sections of research reports, manuscripts, and regulatory submissions.Methodological Development: Stay abreast of advancements in statistical methodologies and RWE techniques, and incorporate innovative approaches into study designs and analyses.Mentor junior statisticians and provide training on best practices in RWE and statistical analysis.Regulatory & Compliance: Ensure adherence to relevant regulatory guidelines, industry standards, and ethical considerations in the conduct of RWE studies.Contribute to the preparation and review of regulatory submissions and responses to regulatory inquiries.
Qualifications: Education: Ph.D. or Master’s degree in Biostatistics, Statistics, Epidemiology, or a related field.Experience: Minimum of 5-7 years of experience in biostatistics, with a strong emphasis on Real World Evidence.Proven track record of leading and executing complex RWE studies and analyses.Experience with large healthcare datasets, including EHRs, claims data, and patient registries.Technical Skills: Expertise in statistical software such as SAS, R, or Python.Strong knowledge of statistical methodologies relevant to observational studies and real-world data analysis.Familiarity with data management tools and techniques.Soft Skills: Excellent analytical and problem-solving skills, with the ability to interpret and communicate complex statistical results.Strong collaboration and interpersonal skills, with the ability to work effectively in a team-oriented environment.Exceptional attention to detail and organizational skills.

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