Biostatistician

The Opportunity

We are currently recruiting a Biostatistician for a flexible, part-time consulting role. You will act as a domain expert, establishing the primary benchmark for AI-driven results to ensure our system delivers outputs that are technically sound, meet regulatory standards, and reflect the latest requirements from regulatory agencies. We engage with domain experts to help design and build these tasks, and help us with what we simply do not know.

This engagement is designed to fit around existing commitments, at approximately 5–20 hours per week. Day to day that might look like any or all of the following sorts of activities (and more):

• Knowledge sharing about "day-in-the-life" as an expert working with data in these domains to assemble regulatory submissions.
• Describing common tasks or problems where AI could be of value in your workflows.
• Identify + describe internal pharma systems that are commonly used for standard workflows.
• Generate or review reference ground-truth artifacts to evaluate against - reports, data files, modules, etc.
• Identify + add realistic sources of variance or data corruption in study data.
• Identify and correct discrepancies in data quality.

Qualifications

• 10+ years of experience in biostatistical applications within biotech or pharma, preferably at a sponsor.
• Graduate degree (Ph.D. preferred) in Statistics, Biostatistics, or a similar discipline.
• Proven expertise in crafting SAPs, determining sample sizes, and designing early-phase (I/II) clinical trials.
• Deep familiarity with ICH guidelines and FDA regulatory standards, including direct experience with CSRs and IND filings.

Why join us?

• Remote/US based
• Flexible hours / flexible time zone - 5-20 hours per week

Note: For consulting opportunities, we do not offer benefits.