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Senior Biostatistical Data Analyst

1 month ago


Comuna Sănduleşti, Cluj, United States Abbott Full time
Overview

Abbott is a leading global healthcare company that provides innovative solutions for patients and consumers. Our diverse portfolio of products and services spans the spectrum of healthcare, with a focus on diagnostics, medical devices, nutritionals, and branded generic medicines.

Job Summary

We are seeking a highly skilled Senior Biostatistical Data Analyst to join our Clinical Research team in Abbott Medical Devices. The successful candidate will provide statistical support to the Biostatistics Supervisor/Manager and the Cardiovascular Division (CVD) for clinical studies. This includes providing statistical expertise in statistical programming, checking data quality, preparing analysis datasets, generating and/or validating data listing, and tables/reports as well as performing statistical analysis and preparing statistical analysis plans.

Responsibilities
  • Work with Biostatistics Supervisor/Manager, clinical or regulatory staff in contributing or preparing statistical section of protocols
  • Assist in data collection forms, writing statistical analysis plans, performing sample size and/or power calculations as appropriate
  • Create randomization, sampling, and other study tools
  • Work with Biostatistics Supervisor/Manager, data management group or clinical study teams to identify the necessary data checking listings or reports (e.g. weekly, biweekly, or ad hoc)
  • Write SAS programs to create reports, handle moderately complex SAS programming issues as well as other related programming issues
  • Performs quality check of the SAS datasets against the source data provided
  • Validate SAS programs, analysis data and results
  • Help study team (CRAs, monitors, etc.) on utilization of data checking reports
  • Work with Biostatistics Supervisor/Manager and study team to determine the timelines
  • Define programming constraints and the contents of the statistical tables and reports, including necessary explanation of data and analysis
  • Identify outstanding data errors and work with clinical study teams to ensure the up-to-date and error free data are available at the time of analysis
  • Prepare datasets for statistical analysis
  • Generate and/or validate patient data listings, statistical analysis summary tables and reports for the regulatory Annual Reports and submissions, DMC/CEC meetings, investigator institutional review boards (IRBs), conferences, etc.
  • Write statistical analysis methodology summary or sections, review summary reports and interpretations to the reports
  • Create, document, and maintain detailed data definition and inventory of all data and program
  • Work with Biostatistics Supervisor/Manager to determine statistical project assignments
  • Reading statistical analysis and clinical study papers and publications
  • Compiles clinical data and relevant background material of the studies for the Biostatistics Supervisor /Manager or study team for review
  • Provide statistical analysis support in the publication and presentation of investigator projects
  • Provide statistical expertise to departments outside of CVD as appropriate, including assisting in the analysis and interpretation of statistical data
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Serve as a back-up for other biostatistician(s)
Requirements
  • M.S. degree in statistics, biostatistics or related majors with 2+ years minimum experience in statistical or SAS programming, OR Bachelor's degree with 2-5+ years' experience will be considered as well
  • SAS Experience is REQUIRED
  • Knowledge of at least one database software package required
Benefits

We offer a competitive salary range of $57,300 - $114,700 based on location and experience. In addition, we provide a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education assistance. We are an equal opportunity employer committed to diversity and inclusion.

About Us

At Abbott, we are passionate about improving the health and wellbeing of people around the world. We are driven by a commitment to innovation, quality, and customer satisfaction. Join our team and become part of a dynamic and growing organization that offers opportunities for career growth and development.