Manager Biostatistics

Location: San Diego, California (Hybrid)- 3x a week

Our client is an innovative, growth-stage biopharmaceutical organization dedicated to advancing therapies that address significant unmet medical needs. The organization is seeking a highly motivated Manager, Biostatistics to play a key role in the design, analysis, interpretation, and reporting of clinical trial data across multiple development programs.

This is a highly visible position that partners closely with Clinical Development, Clinical Operations, Data Management, Statistical Programming, Medical Writing, Regulatory Affairs, and external CRO partners to support strategic decision-making and regulatory submissions. The successful candidate will have the opportunity to influence study design, contribute to development strategy, and help drive critical programs from early development through commercialization.

• Serve as the lead statistician for one or more clinical studies.
• Provide statistical input into protocol development, study design, endpoint selection, randomization methodology, and sample size determination.
• Develop and review Statistical Analysis Plans (SAPs), mock tables, listings, and figures (TLFs).
• Oversee statistical analyses and interpretation of clinical study results.
• Contribute to integrated summaries, clinical study reports, publications, and regulatory submissions.
• Ensure scientific rigor and statistical integrity throughout the clinical development lifecycle.

• Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Data Management, Statistical Programming, and Medical Writing teams.
• Communicate complex statistical concepts to technical and non-technical stakeholders.
• Participate in study team meetings and provide strategic biostatistical guidance.
• Support regulatory interactions and responses to health authority inquiries when needed.

• Collaborate with external CROs and statistical vendors to ensure quality, timelines, and deliverables are achieved.
• Review statistical outputs, datasets, study reports, and submission materials produced by external partners.
• Ensure compliance with applicable regulatory guidelines and industry standards.

• Participate in ongoing data review activities and study monitoring.
• Contribute to submission-ready analyses supporting regulatory filings.
• Ensure adherence to CDISC standards and industry best practices.
• Support post-marketing analyses and real-world evidence initiatives as needed.

• MS or PhD in Biostatistics, Statistics, Mathematics, or a related quantitative discipline.
• 3+ years of biostatistics experience within the pharmaceutical, biotechnology, CRO, or life sciences industry.
• Experience supporting clinical trials across Phase I-IV development.
• Strong knowledge of clinical trial methodology and statistical principles.
• Experience developing SAPs and reviewing study deliverables.
• Proficiency with SAS; familiarity with R is desirable.
• Working knowledge of ICH, FDA, and regulatory guidance.
• Excellent communication, presentation, and stakeholder management skills.

• Oncology, pain management, inflammation, or related therapeutic area experience.
• Experience leading statistical activities within a biotech environment.
• Exposure to regulatory submissions and interactions with health authorities.
• Experience supporting real-world evidence or post-marketing studies.
• Vendor and CRO management experience.

• High visibility within a lean and collaborative clinical development organization.
• Opportunity to influence study design and strategic development decisions.
• Broad exposure across multiple clinical programs and development stages.
• Significant interaction with senior leaders and cross-functional stakeholders.
• Ability to make a meaningful impact on programs addressing critical patient needs.

Work Arrangement: Hybrid, San Diego, California (approximately 3 days onsite per week).

Salary: $ base salary + bonus + equity + additional benefits

This position is ideal for a hands-on biostatistics professional seeking greater ownership, strategic influence, and visibility within a growing biopharmaceutical organization.