Biostatistician Consultant

Job Summary

Offering a flexible part-time consulting opportunity, the Biostatistician Consultant will act as a domain expert to establish benchmarks for AI-driven results, ensuring outputs are technically sound and meet regulatory standards while working remotely for approximately 5-20 hours per week.

Key responsibilities

• Share knowledge on regulatory submissions and data workflows as an expert in the field
• Identify common tasks where AI can enhance efficiency and describe internal pharma systems used for standard workflows
• Generate and review reference ground-truth artifacts and identify discrepancies in data quality

Required 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