Our client, a biotechnology company, is seeking a Biostatistician to support ongoing clinical trial programs from their Boston office. This contract role involves designing statistical analysis plans, analyzing clinical trial data, and producing reports that support regulatory submissions. The position works closely with clinical operations, data management, and regulatory affairs teams throughout the trial lifecycle.
The Biostatistician will apply statistical methods to interpret trial results, identify trends, and ensure data integrity across multiple concurrent studies. This role requires strong knowledge of biostatistical software and familiarity with FDA and ICH guidelines governing clinical research.
This is a contract engagement suited to a candidate who can work independently, manage competing deadlines across several studies, and communicate statistical findings clearly to non-technical stakeholders.
Responsibilities
Develop statistical analysis plans for clinical trials
Analyze clinical trial data using SAS and R
Prepare tables, listings, and figures for regulatory submissions
Collaborate with data management on database design and edit checks
Review case report forms for statistical accuracy
Support the preparation of clinical study reports
Present statistical findings to clinical and regulatory teams
Ensure compliance with FDA and ICH statistical guidelines
Requirements
Master's degree or PhD in Biostatistics, Statistics, or related field
5 or more years of biostatistics experience in clinical research
Proficiency in SAS and R statistical software
Experience with CDISC data standards
Familiarity with FDA and ICH regulatory guidelines