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.
Accountabilities:
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
