Director – Real World Statistics

Director – Real World Statistics

Domnic Lewis has been mandated to hire for Director – Real World Statistics

Job Title: Director – Real World Statistics

Overview:
As the Director of Real World Statistics, you will focus on applying advanced statistical methodologies to support a rare disease portfolio, with a strong emphasis on disease registry initiatives and regulatory submissions. This role sits within a dedicated Real World Evidence (RWE) capability that combines deep statistical expertise with extensive experience in regulatory applications.

We are seeking a curious, driven, and detail-oriented leader with proven experience in disease registries and longitudinal observational cohorts. You will provide statistical leadership, mentor junior statisticians, and deliver high-quality analyses aligned with regulatory standards.

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
  Master//'s 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.