Celerion

Medical writer

• Celerion is committed to swift, exceptional clinical research through translational medicine.
• Full-time Medical Writer, home based anywhere in the United States; Canada and non-US candidates will not be considered.
• Analyze and interpret safety results of clinical trials, including vital signs, clinical laboratory values, adverse events, electrocardiograms (ECGs), diagnostic procedures, and pharmacodynamic (PD) endpoints.
• Compile, write, and edit Phase I and Phase II clinical study documents including clinical study reports (CSRs), stand-alone safety narratives, and synoptic CSRs.
• Confirm accurate classification of events and medications using standardized coding systems.
• Perform peer QC of safety text, serve as project Report Lead, monitor editorial comments, and ensure regulatory compliance (GCP, ICH) and client specifications.
• Use technology to collaborate with international teams (Veeva, Microsoft 365, SharePoint, SmartSheet), lead client communications, and interact with internal departments.

Medical Writer

Data Analyst

• Provide statistical programming support for early-phase clinical research at Celerion, designing, developing, and maintaining SAS programs to support analysis and reporting of clinical trial data.
• Independently develop, maintain, and process SAS programs, creating analysis data packages (ADaM), statistical analyses, data listings, tables, and figures.
• Perform peer QC, double programming, and validation functions for statistical outputs from studies.
• Lead statistical programming activities on studies and deliverables; assist management and biostatisticians with complex projects.
• Design and implement standardized SAS programs; train and mentor junior programmers; ensure compliance with the statistical analysis plan and departmental procedures.

Senior Data Analyst, Statistical Programming

Research Analyst

• Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
• Celerion, a leader in clinical research, is seeking a full-time Clinical Research Associate (CRA) to perform monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.
• This is a Hybrid position - We are looking for someone that currently lives in the Phoenix, Arizona area - and that is able to go to the Tempe sites on a regular basis.

Medical Writer

Senior Data Analyst, Statistical Programming

Clinical Research Associate - Phoenix, Arizona