Associate Director Biostatistics

Job DetailExperience Level Associate DirectorDegree Type Doctor of Philosophy (PhD)Employment Full TimeWorking Type HybridJob Reference Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful biostatistics initiatives at a global pharmaceutical company. Collaborate on innovative drug development projects with cross-functional teams. Enhance your career in a dynamic, growth-oriented environment.Job DescriptionAssociate Director of Biostatistics OverviewThe Associate Director of Biostatistics plays a pivotal role in driving clinical development strategies for innovative drug candidates.Collaborate with cross-functional teams to design and implement clinical trials aligned with regulatory standards and scientific rigor.Contribute to statistical analysis plans, clinical trial protocols, and regulatory documentation to support drug development initiatives.Provide statistical guidance and expertise throughout the trial lifecycle, ensuring data integrity and compliance.Work with global teams across 19 countries, contributing to the development of groundbreaking pharmaceutical products.Leverage advanced statistical tools and methodologies to enhance trial design and data analysis processes.Engage with regulatory authorities, key opinion leaders, and stakeholders to represent the client effectively.Contribute to scientific publications and articles, showcasing trial data and findings.Join a dynamic organization with two approved products and multiple candidates in late-stage development.Associate Director of Biostatistics Key Responsibilities & DutiesRepresent biostatistics in cross-functional meetings to drive clinical development strategies for drug candidates.Collaborate with Clinical Development, Regulatory, and Operations teams to design and implement clinical trials.Develop statistical sections for clinical trial protocols and contribute to statistical analysis plans.Provide statistical guidance on trial conduct, ensuring adherence to regulatory standards and scientific rigor.Collaborate with Data Management and Statistical Programmers on data summary and analysis.Prepare regulatory documents, including clinical study reports, DSURs, and briefing documents.Manage CRO statistical and programming support to ensure project alignment and quality.Represent the client in regulatory meetings and interactions with international authorities.Contribute to scientific articles and publications summarizing trial data and findings.Associate Director of Biostatistics Job RequirementsPhD in Biostatistics, Statistics, Mathematics, Biology, or related field required.Minimum of seven years of experience in biostatistics or related roles within clinical development.Proficiency in SAS and R programming, Bayesian analysis, and dose-response modeling.Experience with clinical trials through Phase 3 and knowledge of ICH GCP guidelines.Familiarity with CDISC standards, including SDTM, ADaM, and CDASH frameworks.Demonstrated ability to design and conduct adaptive trials and interim analyses.Experience interacting with regulatory authorities, including the US FDA and international bodies.Strong communication skills to represent the client in meetings with stakeholders and regulators.Knowledge of advanced statistical software tools such as EAST. Green Key Resources