Join Our Excellent Team of Professionals

Job Description

• Experienced in designs and analyzes.  Ability to implement, and report findings on targeted statistical research studies as well as provides consultation to investigators and researchers on statistical research approaches.  
• Works closely with Sponsor to develop analysis plans and reporting specifications as well as statistical analysis strategies.  Finalize interpretation and presentation of statistical results.
• Assists in the development of clinical trial documents, case reports, protocols, investigator brochures, and scientific abstracts.
• Reviews and analyzes safety reporting, and other aspects of clinical trial monitoring.
• Develops and documents computer data file structure and programs.  Oversees complex statistical databases; performs or supervises data entry.
• Utilizes a variety of statistical software, methods, and techniques to gather, analyze, and interpret research data to derive pertinent information for research data. 
• Oversees and coordinates the work of statistical support staff, data entry staff, and/or students, as appropriate to the position, on a project, site, or operational basis.
• Performs miscellaneous job-related duties as assigned.  Delivers on time and within budget assigned Projects.

Requirements

• At least Masters degree in Statistics or Biostatistics
• At least 5 years of experience using statistical software in a clinical research environment
• Strong analytical and problem-solving skills is a must have
• Proficient in verbal and written communication skills with good report-writing ability.

• Good interpersonal skills, with a heavy emphasis on the ability to work independently with minimal supervision
• Knowledge and understanding of the principles, concepts, methods, and standards of statistical research.
• Proficient with the computer to process data and to format and generate reports.
• Knowledgeable of current and emerging trends in advanced statistical analysis 
• Experience in data management principles and regulatory requirements for clinical trials and medical research.
• Strong focus and quality and timely delivery of work.
• May work remotely

Job Description

• Responsible for all data management documentation which includes design, updates, and reviews.
• Able to work independently with clinical studies or co-lead a larger study or studies with moderate guidance.
• Oversees and monitors the progress of data management activities with CROs or other vendors on assigned studies.
• Review and provide feedback to the Sponsor on all study documents, Clinical Monitoring plans, and Statistical analysis plans. 
• Maintains all study workbooks and data management files
• Participate in the development of data management SOPs, Work Instructions, and process documents.
• Provide status reports and updates.  
• Responsible for the delivering of exceptional quality data, with focus on delivery of documentation on time, on budget and to quality standards and SOPs
• Review trial validation plan related documents and assist with the development if needed.

Requirements

• 5 years data management experience with clinical trials, Strong interpersonal, communication, organization, critical thinking, and problem-solving skills.
• Demonstrate initiative, have sound judgment and flexibility as required
• Experience in validating clinical data, as well as defining, entering, and processing.
• Proficient in computer programs, implementing of data management processes, and updates. 
• Hold a four-year undergraduate degree
• Can work remotely