Director - Real World Statistics

Overview:

curious, driven, and detail-oriented leader

Key Responsibilities

• Design and implement advanced statistical analyses for regulatory submissions using data from

  disease registries, patient registries, natural history studies, electronic medical records (EMR), and claims data

  .
• Collaborate with registry and cross-functional teams to ensure registry-derived analyses support regulatory strategy and compliance.
• Prepare

  regulatory-quality deliverables

  , including statistical analysis plans, reports, and clinical study reports based on registry data.
• Develop, validate, and apply

  innovative statistical methodologies

  for real-world evidence generation from registry and observational data sources.
• Mentor and guide

  junior statisticians and data scientists

  in regulatory-compliant registry data analysis and best practices.

Essential Qualifications

• PhD

  in Biostatistics, Statistics, Epidemiology, Mathematics, Data Science, or a related discipline with

  6+ years

  of experience in the pharmaceutical, biotechnology, or consulting industry; OR

  Masters degree

  in a relevant field with

  10+ years

  of industry experience.
• Strong analytical, problem-solving, and communication skills.
• Ability to collaborate effectively in a matrix environment and maintain consistent availability during standard business hours.

Desirable Qualifications

• Hands-on technical expertise

  in statistical programming (R, SAS, SQL) and familiarity with

  regulatory-compliant programming standards

  .
• Proven track record of

  successful regulatory submissions

  utilizing registry or real-world data.
• In-depth understanding of

  regulatory standards and frameworks

  , including ICH guidelines, FDA Real-World Evidence Framework, and EMA guidance on registry-based studies.
• Expertise in

  registry-based regulatory submissions

  and

  natural history studies

  .
• Demonstrated ability to build and maintain strong relationships with

  regulatory authorities

  and lead

  multi-disciplinary statistical projects

  focused on regulatory outcomes.