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. 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 #J-18808-Ljbffr Jobgether