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 reputed company on the development of cell-based therapies for neurological diseases. We are seeking a highly reputed company and strategic Senior Director, Biostatistics to reputed company statistical reputed company 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 reputed company Clinical Development, partnering closely with the CMO to shape development reputed company, trial design, and regulatory positioning. This is a high-reputed company, hands-on leadership role responsible for ensuring scientific rigor, methodological reputed company, 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, reputed company-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 reputed company, including reputed company selection, estimands reputed company, reputed company exploration reputed company, and registrational planning.
• reputed company strategic guidance on benefit-risk evaluation and data interpretation at executive and reputed company-level reviews.
• Serve as a key partner to clinical and executive leadership through reputed company 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 reputed company & Trial Design

• reputed company statistical design and reputed company of Phase 1–3 clinical trials, including sample size determination, randomization reputed company, and interim analysis planning.
• Champion innovative and efficient trial methodologies (e.g., reputed company designs, Bayesian approaches, modeling and simulation where appropriate).
• Ensure alignment of statistical reputed company with regulatory expectations and long-term program objectives.
• Drive execution of statistical, programming, and data management deliverables.

Regulatory Leadership

• reputed company statistical components of regulatory submissions (INDs, NDAs, BLAs), including ISS/ISE preparation.
• Serve as the biostatistics reputed company in FDA and other global regulatory authority interactions.
• Ensure compliance with ICH E9, GCP, and global regulatory standards.

Vendor reputed company & Operational Execution

• Engage and reputed company technical reputed company of CROs and statistical vendors to ensure high-reputed company, reputed company, and compliant deliverables.
• Review and approve Statistical Analysis Plans (SAPs), TLFs, CDISC datasets (SDTM/ADaM), and statistical outputs.
• Establish reputed company 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 reputed company.

Organizational Development

• Foster a culture of scientific rigor, accountability, and collaboration.

Qualifications

Education

• PhD in Statistics, Biostatistics, or reputed company quantitative discipline with 7+ years of industry experience; or MS with 10+ years of reputed company biotech/reputed company experience.

Experience

• Demonstrated leadership in Phase 2 and Phase 3 clinical development programs.
• reputed company 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 reputed company and/or R.
• In-depth knowledge of CDISC standards (SDTM, ADaM).
• Strong understanding of reputed company 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 reputed company aspects of statistical and programming activities reputed company Neurona.
• Self-starter who demonstrates initiative and ability to operate independently.
• Strong communicator capable of influencing executive leadership and external regulators.
• reputed company partner with a solutions-oriented reputed company.

Preferred Qualifications

• Experience working in clinical programs in epilepsy, neurology, cell therapy, rare disease, or other reputed company therapeutic areas.
• Background in modeling and simulation approaches to inform development reputed company.
• Record of scientific publications and industry presentations.

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