Sr. Director, Biostatistics
Sr. Director, Biostatistics
Location: South San Francisco, CA or Remote
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases. We are seeking a highly experienced and strategic Senior Director, Biostatistics to lead statistical strategy and execution across our clinical-stage cell therapy programs.
Reporting directly to the Chief Medical Officer, this individual will serve as the senior statistical leader within Clinical Development, partnering closely with the CMO to shape development strategy, trial design, and regulatory positioning. This is a high-impact, hands-on leadership role responsible for ensuring scientific rigor, methodological excellence, and regulatory readiness across Phase 1–3 clinical trials.
The ideal candidate brings deep technical expertise, strong regulatory experience, and the ability to operate independently in a fast-paced, growth-stage biotech environment.
Key Responsibilities
Clinical Development Partnership
• Serve as the primary statistical advisor to the Chief Medical Officer and Clinical Development leadership.
• Shape overall development strategy, including endpoint selection, estimands framework, dose exploration strategy, and registrational planning.
• Provide strategic guidance on benefit-risk evaluation and data interpretation at executive and Board-level reviews.
• Serve as a key partner to clinical and executive leadership through close understanding of Neurona’s internal data, external competitors, and relevant precedented programs.
• Ensure alignment between clinical, statistical, programming, and data management activities; drive execution of relevant activities.
Statistical Strategy & Trial Design
• Lead statistical design and oversight of Phase 1–3 clinical trials, including sample size determination, randomization methods, and interim analysis planning.
• Champion innovative and efficient trial methodologies (e.g., adaptive designs, Bayesian approaches, modeling and simulation where appropriate).
• Ensure alignment of statistical strategy with regulatory expectations and long-term program objectives.
• Drive execution of statistical, programming, and data management deliverables.
Regulatory Leadership
• Direct statistical components of regulatory submissions (INDs, NDAs, BLAs), including ISS/ISE preparation.
• Serve as the biostatistics lead in FDA and other global regulatory authority interactions.
• Ensure compliance with ICH E9, GCP, and global regulatory standards.
Vendor Oversight & Operational Execution
• Engage and provide technical oversight of CROs and statistical vendors to ensure high-quality, timely, and compliant deliverables.
• Review and approve Statistical Analysis Plans (SAPs), TLFs, CDISC datasets (SDTM/ADaM), and statistical outputs.
• Establish scalable processes and standards appropriate for a growing clinical organization.
Cross-Functional Collaboration
• Partner closely with Clinical Operations, Regulatory Affairs, and Medical Affairs.
• Support data-driven decision-making across governance forums.
• Contribute to publication planning and scientific communication strategy.
Organizational Development
• Foster a culture of scientific rigor, accountability, and collaboration.
Qualifications
Education
• PhD in Statistics, Biostatistics, or related quantitative discipline with 7+ years of industry experience; or MS with 10+ years of progressive biotech/pharma experience.
Experience
• Demonstrated leadership in Phase 2 and Phase 3 clinical development programs.
• Direct experience supporting global regulatory submissions (NDA/BLA preferred).
• Experience interacting directly with regulatory agencies (FDA strongly preferred).
• Prior experience in clinical-stage biotech environments preferred.
Technical Expertise
• Strong programming proficiency in SAS and/or R.
• In-depth knowledge of CDISC standards (SDTM, ADaM).
• Strong understanding of adaptive trial design and innovative statistical methodologies.
• Comprehensive knowledge of ICH-GCP and global regulatory requirements.
Leadership Competencies
• Strategic thinker with strong execution capability.
• Comfortable being hands-on and accountable for all aspects of statistical and programming activities within Neurona.
• Self-starter who demonstrates initiative and ability to operate independently.
• Strong communicator capable of influencing executive leadership and external regulators.
• Collaborative partner with a solutions-oriented mindset.
Preferred Qualifications
• Experience working in clinical programs in epilepsy, neurology, cell therapy, rare disease, or other complex therapeutic areas.
• Background in modeling and simulation approaches to inform development strategy.
• Record of scientific publications and industry presentations.
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Location: South San Francisco, CA or Remote
Neurona Therapeutics is a clinical-stage biotechnology company based in South San Francisco focused on the development of cell-based therapies for neurological diseases. We are seeking a highly experienced and strategic Senior Director, Biostatistics to lead statistical strategy and execution across our clinical-stage cell therapy programs.
Reporting directly to the Chief Medical Officer, this individual will serve as the senior statistical leader within Clinical Development, partnering closely with the CMO to shape development strategy, trial design, and regulatory positioning. This is a high-impact, hands-on leadership role responsible for ensuring scientific rigor, methodological excellence, and regulatory readiness across Phase 1–3 clinical trials.
The ideal candidate brings deep technical expertise, strong regulatory experience, and the ability to operate independently in a fast-paced, growth-stage biotech environment.
Key Responsibilities
Clinical Development Partnership
• Serve as the primary statistical advisor to the Chief Medical Officer and Clinical Development leadership.
• Shape overall development strategy, including endpoint selection, estimands framework, dose exploration strategy, and registrational planning.
• Provide strategic guidance on benefit-risk evaluation and data interpretation at executive and Board-level reviews.
• Serve as a key partner to clinical and executive leadership through close understanding of Neurona’s internal data, external competitors, and relevant precedented programs.
• Ensure alignment between clinical, statistical, programming, and data management activities; drive execution of relevant activities.
Statistical Strategy & Trial Design
• Lead statistical design and oversight of Phase 1–3 clinical trials, including sample size determination, randomization methods, and interim analysis planning.
• Champion innovative and efficient trial methodologies (e.g., adaptive designs, Bayesian approaches, modeling and simulation where appropriate).
• Ensure alignment of statistical strategy with regulatory expectations and long-term program objectives.
• Drive execution of statistical, programming, and data management deliverables.
Regulatory Leadership
• Direct statistical components of regulatory submissions (INDs, NDAs, BLAs), including ISS/ISE preparation.
• Serve as the biostatistics lead in FDA and other global regulatory authority interactions.
• Ensure compliance with ICH E9, GCP, and global regulatory standards.
Vendor Oversight & Operational Execution
• Engage and provide technical oversight of CROs and statistical vendors to ensure high-quality, timely, and compliant deliverables.
• Review and approve Statistical Analysis Plans (SAPs), TLFs, CDISC datasets (SDTM/ADaM), and statistical outputs.
• Establish scalable processes and standards appropriate for a growing clinical organization.
Cross-Functional Collaboration
• Partner closely with Clinical Operations, Regulatory Affairs, and Medical Affairs.
• Support data-driven decision-making across governance forums.
• Contribute to publication planning and scientific communication strategy.
Organizational Development
• Foster a culture of scientific rigor, accountability, and collaboration.
Qualifications
Education
• PhD in Statistics, Biostatistics, or related quantitative discipline with 7+ years of industry experience; or MS with 10+ years of progressive biotech/pharma experience.
Experience
• Demonstrated leadership in Phase 2 and Phase 3 clinical development programs.
• Direct experience supporting global regulatory submissions (NDA/BLA preferred).
• Experience interacting directly with regulatory agencies (FDA strongly preferred).
• Prior experience in clinical-stage biotech environments preferred.
Technical Expertise
• Strong programming proficiency in SAS and/or R.
• In-depth knowledge of CDISC standards (SDTM, ADaM).
• Strong understanding of adaptive trial design and innovative statistical methodologies.
• Comprehensive knowledge of ICH-GCP and global regulatory requirements.
Leadership Competencies
• Strategic thinker with strong execution capability.
• Comfortable being hands-on and accountable for all aspects of statistical and programming activities within Neurona.
• Self-starter who demonstrates initiative and ability to operate independently.
• Strong communicator capable of influencing executive leadership and external regulators.
• Collaborative partner with a solutions-oriented mindset.
Preferred Qualifications
• Experience working in clinical programs in epilepsy, neurology, cell therapy, rare disease, or other complex therapeutic areas.
• Background in modeling and simulation approaches to inform development strategy.
• Record of scientific publications and industry presentations.
```
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