Biostatistiker (m/w/d)
Core
Planning, execution, and documentation of statistical analyses for Phase I-II clinical trials, including sample size calculation, randomization, and report creation.
Role type
Biostatistician (clinical trials)
Builds
Statistical analysis plans, study reports, and validated datasets for clinical trials.
Domain
Pharmaceutical industry / Clinical research
Required skills
Statistical methods for clinical/observational studies, SAS programming, Sample size calculation, Randomization, Regulatory standards (ICH-GCP, CDISC), SOP creation
Preferred skills
R programming, Experience with CROs or pharma industry
Technologies
SAS, R
Responsibilities
Create and review statistical analysis plans, Validate statistical evaluations and datasets, Collaborate with Clinical Data Management and Medical Writing, Ensure compliance with quality and regulatory requirements
Seniority
Mid-level, hands-on IC