MINIMUM QUALIFICATIONS

• Master’s degree (MS, ScM, MPH, etc.) in Biostatistics, Statistics, Data Science, or a related field or equivalent combination of education, experience, and training;
• 2 years’ experience with data management and statistical programming using R, SAS, and/or SQL;
• 2 years’ experience with electronic data capture (EDC) systems, particularly REDCap;
• 2 years’ experience with clinical trial data structures, research methodologies, and/or regulatory compliance;
• Intermediate proficiency with Microsoft Excel, Word, Access and Outlook with the ability to adapt to a range of database applications.

Candidates whose resumes highlight the following previous experience will be prioritized:

• Demonstrated experience working in and fostering an environment of respect, professionalism and civility with a population of faculty, staff, and students from various backgrounds and experiences, or a commitment to do so as a staff member at VCU;
• Intermediate proficiency with data entry and word processing skills, with the ability to analyze and interpret information effectively;
• Intermediate organizational abilities and a keen eye for detail to ensure accuracy and efficiency in all tasks;
• Clear and professional written and verbal communication skills, with the ability to interact effectively with colleagues and stakeholders;
• Interpersonal skills, capable of building relationships and collaborating with team members at all levels to gather information and support compliance efforts;
• Problem-solving and organizational aptitude, with the ability to manage multiple tasks and meet deadlines in a dynamic environment.

Please note VCU is not able to provide current or ongoing visa sponsorship for this position.

PREFERRED QUALIFICATIONS

• Doctoral degree or equivalent combination of education, experience, and training;
• 2 years’ experience with oncology clinical trials or biomedical research data management;
• 2 years’ experience with clinical trials management systems (CTMS) such as OnCore;
• Prior exposure to ClinicalTrials.gov reporting and FDA data submission requirements;
• Advanced proficiency with Microsoft Excel, Word, Access and Outlook with the ability to adapt to a range of database applications;
• Past productivity as documented by publications.
  Please let us know if you were referred by a current Massey employee to ensure we honor our commitment to the Employee Referral Program.

DUTIES & RESPONSIBILITIES

Please note VCU is not able to provide current or ongoing visa sponsorship for this position.

POSITION PRIMARY PURPOSE AND GENERAL RESPONSIBILITIES

The Massey Comprehensive Cancer Center (MCCC) Biostatistics Shared Resource (BSSR) seeks to hire a data management and reporting specialist to support clinical cancer research, serving as an administrative liaison of data between the Clinical Trials Office (CTO) and the BSSR. The CTO includes a wide spectrum of oncology clinical studies and trials as well as clinical cancer researchers, the clinical research office, and fellow biostatisticians. Scientists strictly follow Good Clinical Practices (GCP) and all current laws, regulations, guidance, policies, and procedures developed by the Institutional Review Board (IRB), Code of Federal Regulations (CFR), and all federal, state, and local regulatory entities. Responsibilities of the Data Manager may be independent or as a member of a team. They work under general supervision, resolving routine-to-complex issues independently and referring more complex issues to an upper-level manager. This individual will report to the director of the BSSR but will work closely with key personnel within the CTO, including the CTO director, to ensure database development is in compliance with Common Data Elements (CDE).
The Data Manager will involve highly collaborative interactions with MCCC staff and investigators, working alongside other staff to ensure quality control on various projects and attend core/project meetings. In addition to the responsibilities listed below, other job responsibilities may be assigned with emphasis on:
1. Data capture and management for oncology clinical trials (50%). Work with the Clinical Trials Office personnel to design and create databases for clinical studies and trials.
a. Develop and maintain REDCap databases.
2. Report generation for clinical trials (25%). Help support on-trial monitoring by planning and creating regular reports on accrual, data quality, safety and (in some cases) efficacy. Oversee development and delivery of tables and reports for ClinicalTrials.gov reporting for all trials.
a. Write, modify, maintain, and validate computer programs for project reports.
b. Review and update statistical analysis plans to ensure accuracy.
c. Run systematic reports for clinical trials.
3. Create analysis data sets for clinical and translational studies (25%). Work with biostatistical teams to organize trial and study data into analyzable formats, provide basic summaries, Tables and Figures, conduct basic biostatistical analyses (ex. correlative studies), and assist with manuscript writing and preparation.
a. Develop analysis datasets using data from electronic data capture systems and registry data systems.