EX Squared is hiring an Associate Director of Biostatistics to provide statistical leadership and oversight for our clinical research programs. This role is central to ensuring the scientific integrity and regulatory compliance of our data analysis.
What You'll Do
- Lead the statistical design, planning, and analysis for clinical studies and regulatory submissions
- Develop and review statistical analysis plans, study protocols, and final study reports
- Provide strategic biostatistical input and guidance to cross-functional project teams
- Oversee the production and quality control of statistical outputs, tables, listings, and figures
- Collaborate with data management and programming teams to ensure data integrity and analysis readiness
- Represent the biostatistics function in interactions with regulatory agencies and external partners
What We're Looking For
- Advanced degree (Ph.D. or M.S.) in Biostatistics, Statistics, or a related field
- 7+ years of biostatistics experience within the pharmaceutical, biotechnology, or CRO industry
- Proven track record of leading statistical efforts for clinical trials from Phase I through Phase IV
- Expert knowledge of statistical methodologies, CDISC standards (SDTM, ADaM), and regulatory requirements (FDA, EMA)
- Proficiency with statistical programming in SAS and/or R
- Strong leadership, project management, and communication skills
Work Mode
This is a remote position requiring the candidate to be physically located within the state of Florida.
EX Squared is an equal opportunity employer.
