A biotech company is looking for a statistician with strong R and Python skills to support clinical trial analysis. You will produce statistical analysis plans and contribute directly to regulatory submissions.
Responsibilities
Develop statistical analysis plans for Phase II/III trials
Perform statistical programming for interim and final analyses
Validate SAS or R programs from CRO partners
Support regulatory response to statistical questions
Present results to clinical and regulatory teams
Requirements
Biostatistics or statistics graduate degree preferred
Strong R (tidyverse, survival, mixed models) and/or Python
Familiarity with ICH E9 guidelines
Experience with CDISC data standards (SDTM, ADaM)
Able to work independently on regulated documentation