Principal Biostatistician, Clinical Trials Lead - Remote

Be The Match; Minneapolis (MN); Remote; USD 90,000 - 130,000; Full time

Job summary

Be The Match is seeking a Principal Biostatistician, Clinical Trials Lead to support clinical trial research studies. This remote role involves mentoring staff, overseeing trial activities, and providing statistical expertise in hematopoietic cell transplantation. Ideal candidates will have a PhD and experience in clinical trials, with strong skills in SAS programming and statistical analysis.

Benefits

Comprehensive health benefits

Retirement plan

Paid time off

Qualifications

• PhD with substantial experience in clinical or biomedical study analysis.
• Experience with Phase I-IV clinical trials.
• Ability to explain statistical concepts to non-statisticians.

Responsibilities

• Mentor biostatisticians and oversee trial activities.
• Conduct intricate statistical analyses and contribute to reports.
• Develop and execute complex analysis strategies.

Skills

Statistical analysis

SAS programming

Problem-solving

Communication

Education

PhD in a relevant field

Tools

Medidata Rave

Veeva

Job description

Principal Biostatistician, Clinical Trials Lead - Remote Nov, Post Date G Requisition

POSITION SUMMARY :

Please apply using a laptop or desktop computer.

The Center for International Blood and Marrow Transplant Research (CIBMTR) and the Clinical Research Organization (CRO) Services team provide 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 supports clinical trial research studies that align with NMDP's mission, vision, and strategic plan. Responsibilities include mentoring biostatisticians, overseeing trial activities, and providing statistical support for assigned trials. The role also involves training new biostatisticians and leading junior team members. This is a remote position (US).

ACCOUNTABILITIES :

1. Leverage statistical expertise to develop and execute complex analysis strategies using software like SAS and R.
2. Contribute to analysis plans, protocol design, statistical reports, and sections of clinical reports.
3. Advise proactively on analysis processes from proposal to project completion.
4. Ensure quality by reviewing data sets and statistical analysis deliverables.
5. Coach and mentor junior team members.
6. Create and update department SOPs and work instructions to improve efficiency.

PERFORM :

1. Conduct intricate statistical analyses and contribute to reports.
2. Explore innovative approaches, including adaptive design applications, in clinical research.
3. Serve as the primary statistician from protocol design to regulatory submissions.
4. Review CRFs, database checks, and instructions for CRF completion.
5. Produce randomization schedules and manage blinding/unblinding processes.
6. Develop and review IAPs, SAPs, and TLF shells.
7. Perform programming, data cleaning, and validation of datasets and TLFs.
8. Develop statistical methods and write sections of reports and manuscripts.
9. Perform descriptive and imputation data analyses.
10. Interact with DSMBs and advise on statistical methodology across departments.

REQUIRED QUALIFICATIONS :

Knowledge of :

• Clinical trial methodology and data management tools (Medidata Rave, Veeva preferred).
• Fundamental statistical concepts and research study design.
• Ability to explain statistical concepts to non-statisticians.
• Proficiency in SAS and other statistical methods for clinical trials.

Ability to :

• Independently perform SAS programming and statistical analyses.
• Problem-solve effectively and communicate clearly.
• Manage multiple projects and meet deadlines.
• Use Microsoft Office and internet tools proficiently.
• Occasionally travel overnight.

Education / Experience :

• PhD in a relevant field with substantial experience in clinical or biomedical study analysis.
• Experience with Phase I-IV clinical trials.

PREFERRED QUALIFICATIONS :

• Knowledge of GCP, FDA regulations, SDTM/ADaM standards, and industry experience.
• Strong interpersonal skills and experience working with diverse populations and health equity initiatives.

Be The Match offers comprehensive benefits including health, retirement, paid time off, and more. For additional details, please refer to the provided link.

Additional Information

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

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