Associate Director / Director Biostatistics

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director / Director Biostatistics in United States.

This role offers the opportunity to lead the full scope of statistical strategy and execution for clinical development programs in a dynamic, pre-commercial biotech environment. The Associate Director / Director of Biostatistics will design, analyze, and interpret clinical trials while providing statistical leadership across Clinical, Medical, and Regulatory teams. This position involves high-impact contributions to regulatory submissions and program-level decisions, with oversight of both internal teams and external collaborators. The role requires balancing strategic vision with operational execution, ensuring the delivery of high-quality statistical outputs. Collaboration, innovation, and precision are central, with a strong focus on advancing clinical programs and supporting organizational goals. This is a remote role with potential for limited travel and offers the chance to shape the statistical landscape of complex therapeutic programs.

• Lead statistical strategy and execution for assigned clinical programs, including trial design, endpoints, estimands, and sample size calculations
• Provide statistical leadership on Study Executive Teams and Clinical Development Teams, ensuring rigorous analysis and quality outputs
• Contribute to regulatory submissions, including NDA readiness, and represent Biostatistics in interactions with regulatory authorities
• Oversee internal teams and external CROs, ensuring quality, timeliness, and compliance of statistical deliverables
• Interpret and validate analysis results for study reports, publications, presentations, and regulatory documents
• Drive continuous improvement initiatives across Biostatistics processes and cross-functional collaborations
• Provide mentorship and oversight to statistical programmers, supporting QC and validation activities

Requirements:

• PhD in Biostatistics, Statistics, or related field with ~8+ years of industry experience, or MS with ~11+ years in drug development
• Extensive experience in pharmaceutical/biotech industry, including study-level or program-level statistical leadership
• Strong background in clinical trial design, cross-functional collaboration, and regulatory submissions (NDA/BLA)
• Experience overseeing CROs and supervising programming deliverables or QC activities
• Proficient in CDISC standards, data structures, and statistical methodologies; working knowledge of SAS and/or R
• Demonstrated ability to communicate complex statistical concepts to non-statistical audiences
• Analytical rigor, pragmatic execution mindset, and experience applying innovative statistical methodologies
• Experience with outcomes research and chronic disease therapeutic areas is preferred
• Ability to lead in a matrixed environment, balancing urgency with quality and compliance

Benefits:

• Competitive salary: $200,000 – $230,000
• Comprehensive medical, dental, and vision coverage
• Remote work flexibility with occasional travel (~10%)
• Retirement plan with employer match
• Paid Time Off and flexible leave policies
• Participation in incentive plans based on individual and company performance
• Professional development opportunities in a high-growth, innovative biotech environment