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
This is a fantastic opportunity to contribute meaningfully to global clinical development programs within a vibrant, growing organization.
