Principal Biostatistician (FTE or Contract)
Core
Lead statistical analysis, reporting, and programming for clinical trials, serving life sciences clients to accelerate clinical development.
Role type
Principal Biostatistician (Senior IC)
Builds
Statistical analysis reports, analysis datasets, clinical tables, listings, graphs, and randomization schedules for clinical trials.
Domain
Life Sciences / Clinical Trials / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming, clinical study design, sample size determination, randomization schedule development, CDISC SDTM/ADAM models, ICH/GCP/21 CFR Part 11 guidelines, statistical analysis plan development, blinded data review, interim analysis, exploratory/post-hoc analysis, regulatory review support, data quality control planning.
Preferred skills
SAS certification, Master's in Statistics or Biostatistics, 10+ years in Pharma/Biotech, experience with IVRS specifications, knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA).
Technologies
SAS, SDTM, ADAM, IVRS
Responsibilities
Develop and validate statistical analysis plans and randomization schedules; conduct statistical analyses and generate clinical study reports; mentor and QC statistical programmers; interact with clients and clinical teams to ensure data specifications and deliverables; perform blinded data reviews and interim analyses; support regulatory reviews and exploratory analyses; ensure compliance with industry quality standards.
Seniority
Principal, hands-on IC with mentorship
