Zero Hour Contract - Statistician - Real World Evidence

Location: Remote / Flexible

Contract Type: Zero Hours Specialist Contractor (Time and Materials)

Function: Statistics / Real World Evidence

About the Role: We are seeking an experienced RWE, Real World Evidence Statistician to provide specialist statistical support for RWE clinical studies on a flexible, zero-hours contract basis. This role focuses on delivering high-quality RWE analyses, quality control activities, and analytical peer review in line with study protocols, Statistical Analysis Plans (SAPs), and regulatory expectations. This is an ideal opportunity for a contractor who enjoys working independently within a defined analytical scope while collaborating with multidisciplinary clinical development teams.

Key Responsibilities: Real World Evidence Data Analysis and Reporting Perform standard real world analysis studies Provide expert statistical input into the design of observational and non-interventional studies using real world data (RWD) Advise on appropriate study designs (e.g. pre/post, cohort, matched comparator, benchmark-aligned analyses) and their limitations Define analytically sound frameworks for outcomes reporting aligned to the intended use (e.g. external credibility rather than regulatory submission) Quality Control and Review Act as an independent statistical expert reviewing client-generated RWE analyses Provide written and verbal critique of analytical approaches and outputs Support refinement of outcomes reporting to improve credibility and external acceptance Peer review analyses performed by other statisticians or programmers Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice Client-Facing Scientific Support Engage directly with sponsors to understand clinical services, data sources, and stakeholder objectives Participate in scientific discussions with clinicians, medical leadership, and external partners Represent Quanticate as an independent, authoritative biometrics partner in RWE discussions Training and Thought Leadership Provide internal guidance or training on RWE methodology and good practice Contribute to white papers, methodological guidance, or thought leadership content in RWE Support development of repeatable RWE analysis frameworks for ongoing client use Contract Details Flexible zero-hours arrangement based on project demand Time and materials engagement model Opportunity to support a range of early-phase clinical development programmes Fully remote working environment

How to Apply: Please submit your CV outlining relevant PK analysis experience and availability for contract work.

About You: Qualifications and Knowledge Expert understanding of observational study design and analysis Deep knowledge of RWE/RWD principles, strengths, and limitations Strong grounding in causal inference concepts, bias, and confounding Working knowledge of relevant guidance (e.g. FDA RWE Framework, EMA guidance, ISPOR good practice) Minimum qualification: MSc in Statistics or related quantitative discipline (or equivalent experience) Experience Typically 10-15 years' experience in pharmaceutical, healthcare, CRO, or academic settings Demonstrated experience delivering independent RWE or outcomes research consultancy Proven ability to review, challenge, and refine non-interventional analyses Experience working with medical record-derived or routinely collected healthcare data

Technical Skills: Proficiency in SAS and/or R; familiarity with real world data structures Ability to explain complex methodological issues clearly and proportionately Strong analytical accuracy and attention to detail Ability to work independently while adhering to defined specifications

Benefits: N/A