Biostatistician

Location: Sunnyvale, CA

Job Description:

  • Initiates and leads statistical aspects in Phase I – IV clinical trial development
  • Leads the design and analysis of clinical trials
  • Maintains the statistical and analytical integrity of clinical trials analyzed
  • Primary statistician responsible for writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports and interpreting statistical results for clinical study reports
  • Applies statistical methodologies to drug development
  • Responsible for being the statistician on clinical research projects and help with SAS programming
  • Provides statistical expertise for study design of clinical trial protocols
  • Writes statistical methods section of the study protocol
  • Develops statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
  • Performs all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
  • Performs validation of statistical results
  • Provides input to key sections of clinical study reports and various regulatory documents
  • Initiates and manages project timelines

Requirements:

  • A minimum of 12 years’ experience in the Pharmaceutical, Medical Products industry, pharmaceutical product development or pharmaceutical formulations development is required
  • Excellent analytical skills with the ability to process scientific and medical data is required
  • Must be able to work independently and in teams
  • Must have a thorough of SAS software
  • Must have demonstrated problem solving abilities
  • Strong organizational skills are required
  • Strong written and verbal communication skills are required
  • Must have demonstrated good interpersonal skills
  • Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
  • Minimum of a Masters in a statistics discipline is required
  • A PhD degree in statistics discipline is preferred
  • Equivalent experience may be accepted