Senior Biostatistician – (Director level but hands-on) Therapeutic Area: CNS / Phase II
We are partnering with a growing biotech organization advancing multiple CNS programs and seeking a Senior Biostatistician who can operate both strategically and hands-on across Phase II studies.
This individual will play a key role in supporting ongoing and upcoming clinical programs in schizophrenia, bipolar disorder, and depression, contributing to study design, protocol development, and execution while working closely with cross-functional teams and external CRO partners.
Key Responsibilities
Lead statistical support for Phase II CNS clinical trials, including study design, protocol development, and statistical analysis planning
Author and review key study documents, including protocols, SAPs, and statistical sections of regulatory submissions
Provide hands-on statistical expertise while also contributing to broader program-level strategy
Collaborate closely with Clinical, Data Management, Programming, and Regulatory teams to ensure alignment across functions
Oversee and manage CRO partners, including review of deliverables, timelines, and quality of outputs
Support interpretation of study results and contribute to internal decision-making and external communications
Ensure statistical integrity and compliance with regulatory standards and industry best practices
Qualifications
PhD in Biostatistics, Statistics, or related field
8+ years of experience in the pharmaceutical or biotech industry