RTI’s Center for Clinical Research Network Coordination (CRNC) seeks a Masters-Level Biostatistician for design, analysis, statistical leadership and support of clinical studies and research networks. The individual will team with statistical and research staff at RTI, collaborate with researchers externally, and lead tasks within projects. The Biostatistician will assist with conceptualization of hypotheses and specific aims, development of study design (research methodology) and statistical analyses, and reporting and publication of research methods and data.
Our collaborative work environment engages researchers to create a diverse portfolio of work in maternal and child health, environmental health, cancer, cardiovascular and other chronic and infectious diseases, and genomics. The position is based in Research Triangle Park, NC; Washington, DC; or as a domestic teleworker.
The Biostatistician will work with staff on the design and conduct of clinical studies including developing statistical analysis plans; providing ongoing study monitoring support; and the evaluation, interpretation, and reporting of study results; and regulatory submission to the FDA.
• Collaborates and contributes to preparation, implementation, and review of clinical trials and other multisite studies.
• Provides statistically sound data collection, experimental design, and data analysis input to meet project objectives and, as applicable, FDA statistical requirements.
• Reviews study protocols, contributing to protocol statistical design and analysis sections.
• Generates treatment allocation assignments.
• Reviews case report forms to ensure that protocol objectives are met and project standards are maintained.
• Develops and documents statistical analysis plans.
• Develops and executes statistical programs to perform analyses and prepare data displays.
• Generates ongoing study status monitoring reports including data monitoring committee reports and data displays for Investigational New Drug (IND) and Investigational Device Exemption (IDE) annual reports.
• Writes results sections of the clinical study reports.
• Supports publication of clinical trial results.
• Remains abreast of new developments in statistics, drug development, and regulatory guidance through literature review and attendance at workshops and professional meetings.
• Master’s in biostatistics, statistics, mathematics, or related field with at least 3 years of clinical trials experience or Bachelor’s degree with at least 5 years of clinical trials experience.
• Experience working with SAS and Excel. Experience with other statistical packages is a plus (e.g., R, Stata, PASS, NQuery, S-Plus, etc.).
• Sound knowledge of theoretical and applied statistics.
• Inquisitive, organized and detail oriented. Must enjoy investigating details and figuring out the solutions to problems (e.g., digging through the details to determine why two values that should match do not).
• A strong interest in developing expertise in the content and specific data we are working with (not just playing with numbers in a vacuum).
• Ability to incorporate quality standards into work routines.
• Effective skills in communication and team collaboration.
• Excellent writing skills as evidenced by cover letter.
• To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status