Manager, Biostatistics

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

About the Opportunity

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.

Key Responsibilities

Clinical Development & Statistical Leadership

• 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.

Cross-Functional Collaboration

• 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.

Vendor & CRO Oversight

• 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.

Data Review & Regulatory Support

• 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.

Qualifications

Required

• 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.

Preferred

• 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.

What Makes This Opportunity Unique

• 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: $110-140,000 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.