The Biostatistician will ensure that clinical development programs (or parts assigned) meet scientific, regulatory and quality requirements. The incumbent will be a statistical leader and project manager for all biostatistics deliverables across assigned clinical development programs.

Perform trial statistician responsibilities as needed, including attendance of study team meetings, authoring SAPs, reviewing CRFs, design of phase 1-3 and PK studies, review of protocols/amendments, conducting exploratory data analyses, and performing just-in-time analyses

  • Perform management of outsourced biostatisticians/programmers, and mentor these team members as required
  • Apply innovative statistical approaches to study design, analysis and data exploration methodologies, including Bayesian adaptive methods to dose finding
  • Plan and track study level activities within programs, including resources; ensure CRO timelines and objectives are met
  • Help establish and maintain data standards, within and across programs (e.g. standardization of Case Report Forms (CRFs), outputs, Statistical Analysis Plans (SAPs)
  • Plan and manage submission activities, like Summary of Clinical Safety (SCS), Summary of Clinical Efficacy (SCE), briefing books, etc.
  • Serve as a general clinical development and statistical resource; participate in non-clinical project activities.
  • Represent Statistics on project teams and serve as statistical contact with clients
  • Provide specifications for structure, content and algorithms for safety and efficacy analysis datasets to programmers
  • Perform quality control of safety and efficacy analysis datasets
  • Write statistical reports and statistical section of the clinical study report (CSR)
  • Actively provide feedback to Clinical Data Management on case report form (CRF) design, data management plan, and edit specifications.
  • MA/MS in Stats or higher with 3+ years
  • Master’s or equivalent degree in Biostatistics, Statistics, Epidemiology, Mathematics or related field
  • 3+ years of biopharmaceutical industry experience, oncology experience preferred
  • 5+ years of Statistician experience
  • Technical abilities and skills in statistical methodologies using SAS, R, SPSS, EAST and other statistical software
  • Regulatory experience required

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