Principal Biostatistician, Clinical Trials

Job Description

POSITION SUMMARY

The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provides a unique resource of data and statistical expertise to the scientific community for addressing important issues in hematopoietic cell transplantation and cellular therapies. This role participates in the statistical support of clinical trial research studies that further the mission, vision, and strategic plan of NMDP. This role is responsible for mentoring the biostatistician team members on clinical trial statistical support, providing oversight of trial activities and performing all statistical support of assigned clinical trials. Additionally, this person will contribute to the training of new biostatisticians and will act as a mentor and leader to the team providing guidance to junior members of the team.

ACCOUNTABILITIES

Mentor, advise, review:

• Leverage statistical expertise; Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R).
• Share knowledge; Provide input to analysis plans, protocol design, statistical reports, statistical sections of clinical reports.
• Impact the process; Be a proactive advisor for all types of analysis from the proposal process through the project life cycle.
• Take quality seriously, Review analysis data sets and quality control all types of statistical analysis deliverables.
• Coach and mentor; Train and uplift junior members of the department.
• Develop efficiencies; Create and modify department SOPs and work instructions.

Perform:

• Execute intricate statistical analyses and provide input to statistical reports.
• Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical research studies
• Act as primary statistician on assigned projects from initial protocol design to final submissions to regulatory bodies, including reporting results in clinicaltrials.gov.
• Review and provide input on case report forms (CRFs), database validation checks, and CRF completion instructions.
• Produce randomization schedules; leads blinding and unblinding processes
• Develop and review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) and table, listing and figure (TLF) shells, as needed.
• Perform the statistical analysis by independently programming and cleaning derived datasets and TLFs; validate the programs per department SOPs.
• Develop statistical methods and results sections of statistical reports, clinical study reports (CSR) and manuscripts.
• Develops and performs descriptive and imputation data analyses.
• Interact with Data and Safety Monitoring Boards (DSMBs), including presenting interim study progress.

Act as statistical consultant within Patient Outcomes and Experience department and to other NMDP departments advising on proper statistical methodology and techniques. REQUI...