Job Description

Director - Real World Statistics

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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.