Director, Statistical Innovation

Role Summary

The Director, Statistical Innovation (DSI) leads the design and planning of innovative development programs and clinical trials, providing critical expertise and leadership in advanced study designs and analytical methods.They guide product strategy, study design, and cross-functional collaboration to align statistical approaches with product strategy and evidence generation plans. The role involves building networks across departments and external peers to promote innovative designs and ensure end-to-end design consultation throughout clinical development.

Responsibilities

• Guides 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 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 positive relationships with SDDs, GSLs and the Modeling and Simulation team to ensure a CfDA ‘team’ approach when interacting with product teams
  • Forms relationships with counterparts in EGTs to help drive the importance of Design consultation throughout the end-to-end clinical development process
  • Establishes 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 peers in innovative designs and analysis methods
  • Promotes awareness of innovative designs and analysis methods by coordinating and providing internal training sessions

Qualifications

• Required: Doctorate degree and 4 years of Biostatistics/Statistical experience OR
• Required: Master’s degree and 8 years of Biostatistics/Statistical experience OR
• Required: Bachelor’s degree and 10 years of Biostatistics/Statistical experience
• Preferred: 10 years of post-graduate statistical experience in the biopharmaceutical industry in clinical trial design, implementation, analysis and reporting
• Preferred: Statistical expertise and leadership across drug development phases, regulatory submissions, and payer interactions
• Preferred: Excellent computing, modelling and simulation skills using R, SAS, WinBugs, FACTS, etc. Doctorate in Statistics/Biostatistics and post-graduate statistical experience in the pharmaceutical industry or medical research
• Preferred: Proven experience with both conventional and innovative trial designs (including adaptive and/or Bayesian) in different phases of drug development
• Preferred: Expertise in advanced statistical analysis methods, modeling and simulation
• Preferred: Knowledge of multiple disease areas and related regulatory guidelines
• Preferred: Experience in leading regulatory and/or reimbursement submissions
• Preferred: Strive for innovation and quick adaptation to new industry trends
• Preferred: Well recognized statistical and strategic leadership among statisticians and cross-functional teams
• Preferred: External visibility in biostatistics profession (e.g., through industry committees/forums, links to academia)
• Preferred: Scientific research/publications in one or more areas of statistical science
• Preferred: Strong technical and effective communication skills
• Preferred: Managerial experience directly handling people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Skills

• Strong technical and effective communication skills
• Leadership and ability to influence cross-functional teams
• Strategic thinking with a focus on innovative design and analysis methods

Education

• Doctorate in Biostatistics or Statistics
• Master’s degree in Biostatistics or Statistics
• Bachelor’s degree in a related field