Clinical Research

• Provide expert statistical input and guidance in the development of clinical study protocols, including sample size calculation, randomization, hybrid study designs, real-world evidence studies, and statistical analysis plans.
• Collaborate with cross-functional teams to define study objectives, endpoints, and statistical considerations, ensuring alignment with regulatory requirements and business goals.
• Statistical Analysis: Conduct comprehensive statistical analyses of clinical study data, utilizing appropriate methods such as descriptive and inferential statistics, survival analysis, regression analysis, subgroup analysis, and propensity score analysis (matching, stratification, weighting, covariate adjustment) as necessary.
• Leverage statistical software tools such as SAS to generate accurate and reliable results and learn new languages/tools/techniques as needed.
• Perform advanced statistical modeling and study simulation techniques to support decision-making and optimize study designs.
• Data Management and Quality: Conduct thorough data review and quality control checks to identify any discrepancies or outliers, ensuring data integrity and reliability.
• Results Interpretation and Reporting: Prepare and present statistical analysis results, study findings, and statistical methodologies to internal stakeholders, project teams, and regulatory authorities.
• Contribute to the development of Clinical Study Reports (CSRs), statistical sections of regulatory submissions, and other relevant documents.
• Statistical Expertise and Guidance: Stay abreast of latest statistical methodologies, industry standards, and regulatory guidelines relevant to medical device clinical studies.
• Provide statistical expertise to guide internal teams, including mentoring junior statisticians and cross-functional colleagues on statistical concepts and methods.

Senior Statistician/Biostatistician (US - REMOTE)

Clinical Research Coordinator II

Clinical Research Coordinator I

Clinical Research Coordinator II

Senior Clinical Scientist

Clinical Research Coordinator