Lead Biostatistician / Head of Statistical Sciences

Lead Biostatistician / Head of Statistical Sciences

Bengaluru (Electronic City) / India (5 Days WFO)

Clinical-stage Biotechnology | Regenerative Medicine

The Opportunity

This is a leadership role, not a downstream support position.

As Lead Biostatistician / Head of Statistical Sciences, you will be the statistical authority for clinical programs, responsible for endpoint strategy, SAP ownership, and regulator-ready analytics.

The role may start as a senior fractional / consulting engagement, with a clear pathway to a full-time leadership position as the pipeline expands.

Key Responsibilities

• Own and author Statistical Analysis Plans (SAPs) for early-phase and IND-enabling studies
• Lead endpoint strategy, including multivariate and domain-specific endpoints
• Partner closely with Clinical, Medical, and Regulatory teams on study design and interpretation
• Serve as the statistical point of contact for regulatory interactions (FDA/CBER, DSMBs, IRBs)
• Ensure all analyses are pre-specified, defensible, and audit-ready
• Guide interim analyses, data interpretation, and scientific decision-making
• Establish statistical standards, governance, and best practices as the organization scales

What Were Looking For

• 8+ years of experience in Biostatistics across clinical trials (Phase IIII)
• Strong hands-on experience with SAP authorship and statistical strategy ownership
• Exposure to early-phase / first-in-human studies preferred
• Solid understanding of regulatory expectations (ICH-GCP, FDA, EMA)
• Proficiency in SAS and/or R
• Background in biotech, pharma, or scientific CROs
• Ability to operate in a high-science, fast-moving startup environment