Provide Statistical Input into clinical development plans, study reports, regulatory documents and publications ensuring accurate deliverables.
Job Responsibilities
Provide Statistical Input into clinical development plans, clinical study reports, regulatory submission documents, and publications ensuring accurate deliverables
Perform Sample size calculations, develop statistical analysis plans and lead TLF development
Perform Statistical analyses and validate analysis results
Oversee outsourced statistical CRO activities and deliverables ensuring highest quality
Develop, implement and improve statistical processes and standards
Support and participate in the development of departmental strategies
Interact with Global regulatory authorities
Qualifications
PhD or Masters in Statistics or Biostatistics
6+ years of experience in the Pharmaceutical Industry and/or CRO including submission experience
Excellent knowledge of clinical study designs, statistical methods, adaptive designs, regulatory guidelines (ICH,FDA,EMA) and statistical software like SAS, EAST, and R
Awareness of the bigger picture, strong orientation to quality, innovate and solution thinking
Preferred experience with clinical study designs in Oncology
