Director of Statistical Innovation

  •  

Seattle, WA

Industry: Business Services

  •  

8 - 10 years

Posted 29 days ago

  by    Jenny Ann Nunez

Job Description:

  • Advises Product Strategy and Study Design
  • Promotes innovative design options and fit-for-purpose analysis approaches that address appropriate clinical questions in protocol / program design and balance speed, quality, and cost
  • Provides advisory input in the development of the Global Statistical Strategic Plan (GSSP) to align study design and statistical approaches with product strategy and Evidence Generation Plan (EGP)
  • Reviews key phase 2 and 3 protocols and provides input during the TA TRC review
  • Provides Technical Expertise
  • Provides technical expertise to GSL and EGT as needed on innovative study designs and advanced analytical methods
  • Provides design options and simulation specifications to the Simulation and Modeling team and develops and approves the simulation plan and results
  • Interprets and communicates modeling and simulation results to inform and guide the selection of optimal trial designs
  • Provides guidance and training to the Simulation and Modeling biostatisticians.
  • Builds Cross-functional Network
  • Develops strong partnerships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA 'team' approach when interacting with product teams
  • Builds relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process
  • Builds relationships with TA TRC members to ensure alignment in development strategies
  • Promotes the advancement of innovative designs and analysis methods
  • Builds professional network with external experts in innovative designs and analysis methods

Requirements:

  • Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research
  • 10+ years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, execution, analysis and reporting
  • 5+ years of strategic statistical leadership at product level of at least one complex program or multiple programs of moderate complexity
  • Solid real life experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development
  • Expertise in advanced statistical analysis methods, modeling and simulation
  • Knowledge of multiple disease areas and related regulatory guidelines
  • Experience in leading regulatory and/or reimbursement submissions
  • Drive for innovation and quick adaptation to new industry trends
  • Well recognized statistical and strategic leadership among statisticians and cross-functional teams
  • External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)
  • Scientific research/publications in one or more areas of statistical science
  • Strong technical and effective communication skills
  • Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
  • Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions
  • Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc.