Our client is an established, global biopharma with a deep, diverse pipeline and marketed products that span several therapeutic areas. Currently they are seeking an Associate Director of Biostatistics to support registration-directed clinical development programs and global regulatory submissions. This role reports to the Director Biostatistics and serves as a strategic statistical partner at the center of decision-making, guiding study design, driving analysis strategy, and ensuring data stands up to the highest scientific and regulatory standards. You will work cross-functionally with internal departments and external resources on Biostatistics-related issues, ensure adherence to relevant regulatory requirements and company SOPs, and apply technical expertise to the development of biostatistics standards and procedures. This is a hybrid role, onsite in Princeton, NJ 3 days a week. Serve as lead study biostatistician across development programs and multiple trials. Author statistical analysis plans (SAPs), TFL shells, and key statistical documents. Oversee AdaM specifications and guide the creation of high-quality, submission-ready datasets and outputs. Drive statistical strategy from design through interpretation and clinical study reporting. Conduct exploratory analyses and simulations to inform innovative trial designs. Partner cross-functionally with Clinical, Regulatory, Data Management, Medical Writing, and external collaborators. Provide statistical expertise for Health Authority interactions, publications, posters, and conference presentations. Contribute to the evolution of statistical standards, SOPs, and process improvements. Contribute to the development and implementation of innovation in statistical methodology and trial design; perform simulations to assess various study design options and analysis approaches. You should have: Ph.D. or M.S. in Biostatistics or Statistics 5+ years experience in a pharmaceutical or biotech company (PhD) Demonstrated understanding of Phase I to Phase IV drug development Strong knowledge in the principles and techniques of statistical analysis, interpretation, and clinical relevance Knowledge of statistical analysis software SAS and R NDA/BLA experience with eCTD submission is a plus Strong experience supporting registration-directed clinical trials Expertise in statistical analysis planning, CDISC standards (including AdaM), and TFL development Ability to collaborate effectively across clinical, regulatory, and data management teams Forward-thinking mindset with the ability to manage multiple projects and to identify and resolve issues #J-18808-Ljbffr