[Hiring] Senior Biostatistician @Penfield Search Partners
Role Description
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.
ā¢ Lead statistical support for Phase II CNS clinical trials, including study design, protocol development, and statistical analysis planning
ā¢ Author and review key study documents, including protocols, SAPs, and statistical sections of regulatory submissions
ā¢ Provide hands-on statistical expertise while also contributing to broader program-level strategy
ā¢ Collaborate closely with Clinical, Data Management, Programming, and Regulatory teams to ensure alignment across functions
ā¢ Oversee and manage CRO partners, including review of deliverables, timelines, and quality of outputs
ā¢ Support interpretation of study results and contribute to internal decision-making and external communications
ā¢ Ensure statistical integrity and compliance with regulatory standards and industry best practices
Qualifications
ā¢ PhD in Biostatistics, Statistics, or related field
ā¢ 8+ years of experience in the pharmaceutical or biotech industry
ā¢ Prior experience supporting CNS programs strongly preferred
ā¢ Demonstrated experience supporting Phase II clinical trials, including protocol development and SAP authorship
ā¢ Strong understanding of regulatory expectations and submission requirements
ā¢ Experience with CRO oversight and vendor management
ā¢ Ability to operate both strategically and hands-on in a fast-paced, evolving environment
ā¢ Strong communication skills with the ability to engage cross-functionally and with senior leadership
Apply tot his job
Apply To this Job
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.
ā¢ Lead statistical support for Phase II CNS clinical trials, including study design, protocol development, and statistical analysis planning
ā¢ Author and review key study documents, including protocols, SAPs, and statistical sections of regulatory submissions
ā¢ Provide hands-on statistical expertise while also contributing to broader program-level strategy
ā¢ Collaborate closely with Clinical, Data Management, Programming, and Regulatory teams to ensure alignment across functions
ā¢ Oversee and manage CRO partners, including review of deliverables, timelines, and quality of outputs
ā¢ Support interpretation of study results and contribute to internal decision-making and external communications
ā¢ Ensure statistical integrity and compliance with regulatory standards and industry best practices
Qualifications
ā¢ PhD in Biostatistics, Statistics, or related field
ā¢ 8+ years of experience in the pharmaceutical or biotech industry
ā¢ Prior experience supporting CNS programs strongly preferred
ā¢ Demonstrated experience supporting Phase II clinical trials, including protocol development and SAP authorship
ā¢ Strong understanding of regulatory expectations and submission requirements
ā¢ Experience with CRO oversight and vendor management
ā¢ Ability to operate both strategically and hands-on in a fast-paced, evolving environment
ā¢ Strong communication skills with the ability to engage cross-functionally and with senior leadership
Apply tot his job
Apply To this Job