Right Fit Advisors
Website:
rightfitadvisors.com
Job details:
Senior Biostatistician (Remote)
Are you a biostatistics expert who thrives on designing clinical studies, translating complex data into insights, and influencing critical decisions?
We’re looking for a Senior Biostatistician who can drive statistical strategy from study design through regulatory submission while collaborating cross-functionally to deliver high-impact clinical outcomes. This role is ideal for someone who enjoys both technical depth and strategic influence.
What You’ll Own
- Provide statistical leadership and support across clinical trials
- Contribute to study design, including protocol development and sample size calculations
- Develop Statistical Analysis Plans (SAPs), including dataset and TLG specifications
- Perform statistical analyses and interpret results to guide clinical decisions
- Prepare clinical study reports and integrated summaries for regulatory submissions
- Ensure compliance with regulatory standards, including FDA guidelines and GCP
- Support CRF design, data review guidelines, and data validation planning
- Review and/or develop data transfer specifications for external vendors
- Collaborate cross-functionally with clinical, data, and external partners to meet timelines
Leadership & Impact
- Serve as a key statistical advisor to cross-functional teams
- Translate complex statistical methodologies into clear, actionable insights
- Contribute to the development of standards, tools, and best practices
- Support quality and consistency across statistical programming and reporting processes
What Sets You Up for Success
- Master’s degree in Statistics or related field (PhD preferred)
- 5+ years of experience supporting clinical trials in pharma or biotech
- Strong experience in study design, SAP development, and clinical reporting
- Proficiency in SAS for QC of statistical outputs (efficacy/safety tables)
- Knowledge of R is a plus
- Solid understanding of CDISC standards and regulatory submissions
- Experience with ADaM datasets and validation
- Strong communication skills with the ability to explain complex concepts clearly
Why This Role Stands Out
This isn’t just a support role—you’ll play a critical part in shaping study design, influencing decisions, and driving the success of clinical programs. If you’re looking to combine technical expertise with strategic impact, this is your opportunity.
Click on Apply to know more.