Role: Associate Director of Biostatistics providing statistical leadership across clinical development programs, primarily Phase I to IV trials, for a biotech developing biologics targeting chronic skin diseases like psoriasis.
- Responsibilities include designing studies, developing analysis plans, authoring key statistical documents, managing CRO vendors, and ensuring regulatory compliance.
Qualifications: Ph.D. in Biostatistics or related field with 5+ years (or Masters with 8+ years) experience in clinical trials; expertise in trial design, statistical analysis, and programming (SAS preferred, R a plus); strong knowledge of ICH-GCP, FDA/EMA regulations, and CDISC standards; experience in Immunology or Inflammation highly desirable.
Skills: leadership, independent judgment, cross-functional collaboration, organizational skills, and effective communication.
High-Value: biologics, immunology/inflammation, early to late-stage clinical trials, regulatory documentation, GxP compliance.
Work setup: Remote or hybrid (with 2-3 days in office near Menlo Park, CA or Waltham, MA).
Salary: $182,000–$208,000 plus benefits, equity, and bonus potential.
#J-18808-LjbffrAssociate Director, Biostatistics in boston at Unknown Company
This position is listed as full time and able to be worked remotely.