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.