Senior Biostatistician, Clinical Trials - Remote

Please apply online using a laptop or desktop computer.

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 actively participates in the statistical support of clinical trial research studies that further the mission, vision and strategic plan of NMDP. In addition to contributing their time as a statistician, this role will mentor and train junior biostatisticians. This is a remote position (US).  #LI-Remote

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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.
• Serve as mentor and role model to the team. Train new statisticians on processes, data and statistical methodology.
• Identify areas of growth for the team and presents ideas for process improvements and efficiencies to statistical leaders.
• Develop efficiencies; Create and modify department SOPs and work instructions.

Perform statistical duties:

• Act as primary study statistician and/or lead statistician on assigned protocols from initial protocol/study design to statistical analyses and final submissions to regulatory bodies and/or presentation/publications. This role will provide full scope of statistical support to the study with minimal supervision.
• Collaborate with statistical director and/or protocol chairs on statistical design in protocol development including endpoint selection and statistical method for analysis, sample size and power consideration, interim analysis and safety monitoring.
• Author randomization plan and create treatment tables.
• Write statistical analysis plan and develop tables, listings and figures (TLF) shells.
• Generate statistical programming and reports for safety monitoring, monitoring boards, FDA review and interim/final analyses.
• Conduct interim analysis and final analyses, and other trial closeout tasks including reporting results in clinicaltrials.gov.
• Write statistical sections of the protocol, clinical study reports (CSR), presentations and manuscripts; providing interpretations to statistical reports.
• Implement data validation and data cleaning via statistical programming.
• Advise statistical programmer(s) and/or junior statistician(s) on statistical programming and reporting on the study, by serving as independent programmer, independent reviewer, and/or lead quality validator.
• Collaborate with clinical operation, data management, safety and other functions  to conduct statistical review on case report form, develop data systems and CRF completion instructions; implement blinding management for randomized trials; create operational reports to facilitate monitoring and management of trials.
• Investigate novel approaches (e.g., new applications of adaptive design) for designing and analyzing clinical trials.
• Build and sustain collaborative relationships with individuals in different disciplines within CRO Services and serves as statistical expert and data subject-matter expert for assigned studies.
• Interact with Data and Safety Monitoring Boards (DSMBs), including presenting interim study progress for assigned studies.
• Interact with external sponsor(s) and statistical collaborators outside the organization to address statistical issues for assigned studies.