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.

REQUIRED QUALIFICATIONS: Knowledge of:

• Knowledgeable and experienced in clinical trial methodology.
• Experience and knowledge of clinical data management processes and tools (Medidata Rave and Veeva preferred).
• Demonstrated practical understanding of fundamental statistical concepts and methodologies.
• Proven knowledge of research study design methods, independent problem solving, decision making, and principles, concepts, methods, and standards of statistical analyses.
• Demonstrated ability to explain statistical concepts to non-statisticians to enhance their understanding of the analytical approach.
• Proficiency in statistical methods used to design and assess outcomes of clinical trials.
• Strong research and analysis skills including an understanding of scientific/therapeutic research in general.
• Advanced analytical skills, including high-level experience with SAS.

Ability to:

• Perform SAS programming and statistical analyses for research projects independently.
• Utilize excellent problem-solving skills, with a positive attitude that allows all problems to be broken into manageable parts and tackled.
• Employ excellent written and communication skills, including the ability to provide meticulous documentation of processes and organize materials in a transparent manner.
• Utilize organizational skills and ability to manage multiple projects while meeting deadlines.
• Demonstrate basic Microsoft Office computer software and Internet skills.
• Commit to occasional overnight travel.

Education/Experience:

• PhD degree in relevant field with 5+ years in statistical design and analysis of clinical or biomedical studies or Master's degree in relevant field with 8+ years of experience.
• Experience designing and analyzing Phase I-Phase IV clinical trials.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Preference given to candidates with working knowledge of GCP and FDA regulations, experience working in the pharmaceutical/medical device industry and working knowledge of SDTM/ADaM standards.
• Excellent interpersonal skills that can enable enjoyable collaboration with diverse study staff and investigators.
• Demonstrated success working/collaborating with diverse populations in a role that has focused on improving health equity by working to eliminate health disparities and/or addressing systemic racism.

About the Team NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information