Associate Director of Biostatistics Overview • The 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 & Duties • Represent 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 Requirements • PhD 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.