Principal Biostatistician, Clinical Trials - remote

National Marrow Donor Program; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking a Principal Biostatistician to join their remote team. In this pivotal role, you will leverage your statistical expertise to support clinical trials, mentor junior staff, and contribute to the design and analysis of critical research studies. You will be responsible for executing complex statistical analyses, ensuring data integrity, and collaborating with diverse teams to enhance health equity. If you are passionate about making a difference in the field of clinical research and have a strong background in statistical methodologies, this is an exciting opportunity to advance your career.

Benefits

Medical Benefits

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Time Off

Retirement Plans

Qualifications

• 5+ years of experience in statistical design and analysis of clinical studies.
• Proven knowledge of research study design methods and statistical analyses.

Responsibilities

• Provide statistical support for clinical trials, mentoring junior biostatisticians.
• Develop complex analysis strategies and execute them using SAS and R.

Skills

Statistical Analysis

SAS Programming

Clinical Trial Methodology

Problem Solving

Communication Skills

Research Skills

Education

PhD in relevant field

Master’s degree in relevant field

Tools

SAS

R

Medidata Rave

Veeva

Job description

Principal 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 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. This is a remote position (US). #LI-Remote

RESPONSIBILITIES:

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

PERFORM:

• Execute intricate statistical analyses and provide input to statistical reports.
• Investigate novel approaches 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; lead 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.
• Perform 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:

• 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.

BENEFITS:
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

ADDITIONAL INFORMATION:

• Number of Openings: 1
• Pay Basis: Yearly
• Schedule: Full-time
• Driver Policy: No
• Job Family: Research & Development