Principal Biostatistician (Fully Remote)

📍 Remote | Small Biostatistics Consultancy | Full-time or Contractor

Drive Innovation. Deliver Insights. Shape Clinical Strategy.

Are you a self-directed, creative, and detail-oriented biostatistician ready to take on a pivotal role in a growing consultancy? We're looking for a Principal Biostatistician-Scientist who thrives in a dynamic, fully remote environment and is eager to wear multiple hats as part of a close-knit team supporting biotech and medtech clients on their path to FDA/CMS approvals and high-impact publications.

In this role, you’ll lead and contribute to all aspects of clinical study design, analysis, and reporting. You’ll work directly with clients, project managers, and company leadership — and your work will directly influence both client success and company growth.

What You’ll Do:

• Read and synthesize academic literature to understand client technologies and relevant statistical methodologies
• Design studies and perform power/sample size calculations
• Draft protocols and statistical analysis plans (SAPs) in collaboration with clients
• Conduct ad hoc statistical analyses and develop statistical programs based on SAPs
• Review data deliveries and validate results from fellow biostatisticians
• Edit and review written deliverables, including reports, manuscripts, and submission materials
• Participate in strategic client discussions and contribute to the planning of clinical and regulatory milestones
• Document project workflows and contribute to team collaboration using remote project management tools

What You Bring:

• 10+ years of experience in clinical trials, with significant exposure to medtech
• Proficiency in SAS and R, with a solid understanding of CDISC, SDTM, and ADaM standards
• Strong writing and study design skills, with a keen eye for detail
• Scientific agility — the ability to quickly learn new domains across therapeutic areas and technologies
• Creative problem-solving mindset and strategic thinking
• High level of autonomy, accountability, and self-direction in a fully remote setting
• Experience with in vitro diagnostics (IVD) and/or pharma is a plus

Why This Role?

• Make a visible impact: Your work directly shapes client outcomes and represents the company
• Collaborate and grow: Work with a small, agile team where your voice and ideas matter
• Work your way: Enjoy full flexibility and autonomy in a 100% remote environment
• Shape the future: Play a key role in a growing consultancy with opportunities for expansion and leadership

Ready to take the lead in shaping clinical studies and regulatory strategy for cutting-edge biotech and medtech companies?

🔗 Apply now and bring your expertise to where it makes the biggest difference.