Alliance/Partner Management, Best Practices, Biostatistics, Biotech and Pharmaceutical, Clinical Data Management, Clinical Practices/Protocols, Clinical Support, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Industry Standards, Leadership, Phase II Clinical Trials, Protocol Design, Regulations, Regulatory Compliance, Regulatory Submissions, SAP, Statistics, Vendor/Supplier Management, Writing Skills
Contact: Neisha Camacho/Terra Parsons -
teamnt@penfieldsearch.com
No 3rd party candidates
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
- Prior experience supporting CNS programs strongly preferred
- Demonstrated experience supporting Phase II clinical trials, including protocol development and SAP authorship
- Strong understanding of regulatory expectations and submission requirements
- Experience with CRO oversight and vendor management
- Ability to operate both strategically and hands-on in a fast-paced, evolving environment
- Strong communication skills with the ability to engage cross-functionally and with senior leadership
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Penfield Search Partners