Biostatistician Consultant

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